Friday, February 5, 2010
St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices
St. Jude Medical has received the European CE Mark of approval for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator. The devices are smaller and can deliver a stronger punch than previous generation models, and they feature new heart monitoring algorithms.
These devices feature 40J of delivered energy (45J stored) - the highest energy level available in the industry - helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.Because of the devices' narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company's SJ4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient's chest.
The Unify CRT-D and Fortify ICD also incorporate the new CorVue(TM) pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient's heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.
Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.
In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.
Press release: St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors
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Wednesday, February 3, 2010
Duo Ablation Catheter Going on Trial
The FDA has cleared St. Jude Medical to initiate a clinical trial of the company's Duo irrigated ablation catheter for treatment of atrial fibrillation. The device, which already has the European CE mark, features twelve irrigation ports that should provide better cooling of the electrode during ablation.
The IRASE AF trial is the industry's first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company's Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF, a type of AF that begins suddenly and ends spontaneously. The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.When the first line of therapy for the treatment of paroxysmal AF using antiarrhythmic medication is ineffective, RF ablation is currently recommended as a second line of therapy for long-term cardiac arrhythmia control. The IRASE AF pivotal study intends to determine whether or not ablation using the company's Duo 12 port open irrigated catheter system is safe and effective compared to the other market approved catheter for treatment of symptomatic paroxysmal AF. It will also determine if the ablation catheter can be indicated for the treatment of symptomatic paroxysmal AF.
The trial's primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months.
Press release: St. Jude Medical Announces IRASE AF Clinical Trial to Evaluate Cardiac Ablation Catheter System for Treatment of Atrial Fibrillation...
Product page: Therapy Cool Path Duo...
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Tuesday, January 26, 2010
Melody Transcatheter Artificial Valve Finally Gets Go Ahead in US
The FDA is making Medtronic very proud by awarding the company the first US regulatory approval for a transcatheter cardiac valve replacement. The Melody system is designed to be an alternative option to open heart surgery, and it will now be indicated for peds and adults with congenital heart disease who have dysfunctional right ventricular outflow tract conduits. The Melody Transcatheter Pulmonary Valve and Ensemble Delivery System have received European approval back in 2006. We've been covering this system for the last four years and we are honestly happy to see it's finally making the debut to the cardiac market.
From a statement by the FDA:
Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.
Here's a video of an implanted Melody valve in action:
Press releases: FDA Approves First Percutaneous Heart Valve...; Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted Without Surgery...
Flashbacks: Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children; Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval; Melody Transcatheter Pulmonary Valve Still Being Tested in the US; The Melody Transcatheter Pulmonary Valve
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Thursday, January 21, 2010
HeartMate II LVAD as Permanent Option for Heart Failure
The FDA has just issued clearance for Thoratec Corporation's HeartMate II LVAD (left ventricular assist device) to be used as a permanent therapy in patients with severe heart failure that are not candidates for organ replacement. The system has garnered FDA's approval in April of 2008 as a bridge to transplantation, a typical indication for LVADs. By issuing this latest verdict, the first its kind, FDA is now taking the LVAD industry (and cardiac surgery) to a completely new, larger, and potentially more lucrative market.
From a statement by the FDA:
HeartMate II consists of a small, lightweight blood pump implanted in a patient's chest just below the heart. An electrical cable that powers the blood pump passes through the patient's skin to an external controller worn around the patient's waist.A physician designates the pump's speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump's operation.
"The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment."
In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.
As a condition of the FDA's approval, the company will conduct a post-approval study to further evaluate the device's performance.
FDA press release: FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients...
Product page: HeartMate II...
Flashbacks: FDA Approves Thoratec Heart Pump; HeartMate II Shown Effective In Waiting Transplant Candidates; Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?; HeartMate® II Left Ventricular Assist System
(hat tip: MassDevice)
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Tuesday, January 19, 2010
IMRIS Combination MRI Fluoroscopy Systems for Intraprocedural Multimodal Imaging
IMRIS out of Winnipeg, Canada recently received FDA approval to market the firm's neurovascular and cardiovascular combination MRI/X-ray angiography systems. The IMRISnv and IMRIScardio systems feature MRI scanners that ride on rails attached to the ceiling and a complete fluoroscopy package that can be swung in and out of the surgical field. This combination allows clinicians to quickly evaluate the problem, perform a procedure, and then check back with the MRI to see how it went, all without moving the patient.
IMRISNV features a wide bore 3T MRI scanner and a bi-plane angiography system completely integrated into a single suite that permits the patient to transition quickly and seamlessly between MR imaging and intervention without transporting the patient between modalities. Using IMRISNV, MR images can be taken before and during procedures to assess tissue health, and can also be used in conjunction with the fluoroscopic images during the interventional procedure. On completion of the procedure, new images can be taken to evaluate the intervention.IMRIScardio provides physicians with enhanced images for visualizing the cardiovascular system before, during and after an intervention. The IMRIScardio suite includes a wide bore 1.5T MRI scanner and a single-plane or biplane angiography system providing the ability to alternate between imaging modalities and immediately assess treatment.
Link: IMRIS...
Press release: IMRIS RECEIVES FDA CLEARANCE FOR IMRISNV AND IMRIScardio... (.pdf)
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Friday, January 15, 2010
Transcatheter Mitral Valve Implantation Technology from CardiAQ
Transcatheter aortic and pulmonic valve replacements are shaping up to become attractive alternatives to open heart surgery, as we have seen with products such as Melody Pulmonary Valve and Edwards Sapien Aortic Valve. But the same cannot be said of mitral replacements.
The mitral valve has a complicated anatomy, as well as a precarious intracardiac left AV position that's difficult to access. Then there is also the issue of a complex etiology of mitral regurgitation, such as ring dilation, chordae rupture, or cusp damage. So the transcatheter MVR development has seen its share of failures and difficulties. Now CardiAQ of Winchester, Massachusetts thinks that it has developed a novel percutaneous solution for mitral regurgitation patients that doesn't use a radial force to attach the artificial valve, overcoming the main problem of performing mitral valve replacement. To help move the company's Transcatheter Mitral Valve Implantation (TMVI) forward, the firm just finished a $6.5 million 'Series A' fund raiser, giving us hope that we might be seeing this technology in cath labs within a short period of time.
1. INSERTION. A catheter carrying the replacement valve is threaded through the femoral vein and up into the right atrium of the heart. It is passed through the intra-atrial septum, into the left atrium, and down through the mitral annulus.2. POSITIONING. The valve is partially expanded to engage the ventricular side of the annulus and establish the proper position. While the valve is now functional, it can be recaptured and adjusted prior to final deployment, if necessary.
3. ANCHORING. With the valve in position, the sheath is retracted fully. Foreshortening of the frame creates a clamping action that anchors the valve above and below the annulus.
Company page: CardiAQ...
More from MassDevice...
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Wednesday, January 13, 2010
IntroSpicio 1.2 mm Disposable CMOS Camera for Cardiovascular Angioscopy
Earlier this week we mentioned the Video Scout, what we thought was a small video camera, at only 3mm in diameter. Now we learn of a product from Medigus of Omer, Israel that is less than half the size of the Video Scout. The IntroSpicio 120 CMOS camera has a 1.2mm diameter, but unlike the Video Scout requires external illumination to guide its path. Israel's business newspaper Globes is now reporting that Voyage Medical out of Redwood City, CA (we can't find website link) has purchased $6.5 million worth of these cameras to implement in the firm's upcoming cardiovascular angioscopes.
From Globes [online]:
The camera employs a CMOS sensor developed by TowerJazz Ltd., and which is manufactured at the company's Fab2 in Midgal Ha'Emek using Tower's 0.18-micron CMOS image sensor process.Medigus said that, in a global first, its camera will make it possible to insert a camera directly into the heart through the blood vessels, enabling Voyage Medical's proprietary endoscope to image heart tissue in real time and while performing procedures.
Specifications from the IntroSpicio 120 brochure:
System Components: 1.2mm (outer-diameter) camera, head with optics plus video, processor unit
Image pick-up device: CMOS
Effective pixels: 49,280
Resolution: 220H x 224V
Video outputs: NTSC, VGA
System Functions: Gain, White Balance, Automatic Gain, Control, Red/Blue Enhancement, Brightness, Zoom, Freeze, Print, Save – 4 images, (additional memory – optional).
Power Supply: AC100-240V 50/60Hz
Field of View: 100°
Dimensions: <Camera head> Shape: circular, Outer-diameter: 1.2mm, Length: 5mm
<Camera cable> Length: up to 3 meters
<Video processor box> 300mm(W)x70m(H)x250mm(D)
More from Globes [online]...
Product page: IntroSpicio 120...
IntroSpicio 120 brochure... (.pdf)
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Wednesday, January 6, 2010
Will PHOENIX Combination Delivery System Be TMR of the Future?
Cardiogenesis out of Irvine, CA is reporting that it has submitted an IDE (Investigational Device Exemption) to the FDA "to initiate a safety and feasibility trial for its PHOENIX System in patients with refractory angina." The PHOENIX Revascularization Delivery System is a combination device designed to perform two primary functions:
1. Being equipped with holmium:YAG laser, the system can perform Transmyocardial Revascularization (TMR) during open heart surgeries, a common procedure usually used for end-stage coronary artery disease. During TMR the surgeon makes transmyocardial holes with a laser, and that is thought to be responsible for induction of angiogenesis in myocardium.
2. PHOENIX handpiece is specifically designed to let cardiac surgeons inject "biologic or pharmacologic agents to pre-determined areas of myocardium" during TMR. The hope is that in the future this technology will allow us to provoke a more robust angiogenesis, or maybe, depending on the agent, allow the delivery of positive inotropes to compromised areas of myocardium.
In its press release, Cardiogenesis states that some clinicians in Europe are already experimentally using the PHOENIX System in concert with bone marrow derived stem cells, and that "the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results."
More about the device:
The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of thirty-seven 100 µm diameter fibers, identical to the fiberoptic component currently in use in the FDA approved Sologrip® III and PEARL(TM) 5.0 handpieces. The handpiece has been modified to include three 26 gauge needles positioned around the fiberoptic fibers, which allow precise delivery of biologic/pharmacologic fluids into the tissue surrounding the channels created by the fiberoptic.
The PHOENIX System utilizes the Ho:YAG thermoacoustic stimulated tissue zone and introduces additional potent, therapeutic agents into the targeted myocardium to dramatically enhance the healing process.Improved long-term survival
Reduced cardiac-related hospitalizations
Enduring long-term angina relief (beyond 5 years)
Reduction in anti-anginal and cardiac medications
Improved quality of life
Robotic and thoracoscopic treatment options (PEARLTM) Advances the application of therapeutic biologics in treating heart disease
Convenient combination delivery tool designed for one-handed operation
Precisely and accurately delivers measured biologic to the thermoacoustic stimulated tissue zone
Press release: Cardiogenesis Submits IDE to Initiate a Clinical Trial for Its PHOENIX Combination Delivery System...
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Monday, December 21, 2009
Sutureless ATS 3f Aortic Valve Gets EU Green Light
ATS Medical of Minneapolis, Minnesota has announced winning the CE Mark from the European Union to market its ATS 3f replacement aortic valve. In an attempt at aortic bioprosthesis humor, the company calls it the "original you tube" claiming it functions more like a natural valve compared to competing products.
Features from the product page:
By using a single suture line at the annulus and tacking the commissural tabs to the sinotubular junction (STJ), the continuity between the annulus and the STJ is restored with implantation of the ATS 3f Aortic Bioprosthesis. Maintaining the continuity between the annulus and the STJ, without a second suture line at the sinuses, preserves sinus form and function. Sinuses facilitate better vortex formation early in systole and smooth closure of the aortic vale, thereby avoiding the buildup of abnormal stress in the leaflet. Turbulent flow and greater leaflet stress is a consequence of sinus loss. Loss of sinuses results in leaflet and aortic wall contact, greater regurgitation during a longer systole and abnormal leaflet bending during closure. Because it is tubular, the ATS 3f Aortic Bioprosthesis restores physiologic, non-turbulent trans-prosthetic flow that is indistinguishable from flow across a native aortic valve. The ATS 3f Aortic Bioprosthesis is a stentless pericardial valve that replaces the diseased native aortic leaflets. Since there is no bulky stent, minimal tissue is implanted achieving essentially a 1:1 annulus to orifice ratio and laminar flow, just like a native valve. Because it is tubular, the ATS 3f Aortic Bioprosthesis restores native valve stress distribution to the entire aortic root. The form and function of a native valve is reproduced with the implantation of the ATS 3f Aortic Bioprosthesis resulting in minimal stress at the commissures, just like a native valve.
Press release: Enable is the First and Only Commercially Available Sutureless Surgical Tissue Valve...
Product page: ATS 3f Aortic Bioprosthesis...
Company video describing the product below the fold:
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Friday, December 18, 2009
Cardiopulmonary Bypass Pump Brings Attractive Aesthetics to Grim Situations
In October, LIFEBRIDGE Medizintechnik of Ampfing, Germany won FDA approval for the B2T heart-lung machine. The portable unit is designed to be percutaneously (fem-fem) connected to the patient for quick circulatory support during acute cardiac failure. Last year this system won a red dot product design award.
The unique level of automation allows the system to be ready for use within 5 - 10 minutes and guides the trained user intuitively through the menu on the integrated display in five steps. The Lifebridge reaches a blood flow of up to 6 l/min and is powered by a mains voltage of 110/220V AC. For mobile operation, the system can be switched to battery power for a period of up to 2.5 hours. It contains an automatic seven stage air safety system preventing air embolisms.
Some technical specs:
Blood flow: Up to 6 liters/minute (active drainage, depending on cannulation) Gastransfer: Adult according A.A.M.I Set-up time: Only a few minutes through semi-automatic priming and de-bubbling Max. Support time: 6h Air emboli protection: 7-fold air elimination system Display: Touch screen to guide the user and to monitor the system status Power supply (mains): 110/230 Volt AC or 24 Volt DC Power supply (battery): 2 hours + 30 minutes Weight: 17,5 kg (38 lb) without base station Dimensions: 24 inch x 17 inch x 14 inch (W/H/D) without base station
More from MTB Europe...
Product page: The LIFEBRIDGE B2T...
Press release: Novel Cardio-Pulmonary Support Device LIFEBRIDGE from Germany gains FDA Clearance... (.doc)
red dot design award announcement...
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Thursday, December 10, 2009
TAArget Thoracic Stent Graft Going on Trial
MassDevice is reporting that LeMaitre Vascular out of Burlington won FDA's conditional clearance to go ahead with a feasibility study of the company's TAArget thoracic stent graft. There are some vague conditions to meet before the FDA is fully satisfied -- the company was tight-lipped about it but we suspect aorta safety is something the FDA doesn't take lightly. When these conditions are met, the firm plans to perform a formal study comparing its product with traditional open chest thoracic aorta repair.
Some features of the TAArget from the product page:
Over 250 Custom Sizes TAArget’s configurations include straight and tapered versions from 12 mm to 42 mm diameters with pre-loaded and cartridge loaded delivery options. Cartridge loaded option allows delivery of cuffs and extenders through the original delivery system.Uniform External Fixation Design
Conforms to thoracic arch, allowing flow to native vessels while maintaining a secure position.
Sutureless Design
Eliminates the potential for suture breakage, reducing the risk of graft material tearing.Laminated ePTFE Body
Has a low profile with high tensile strength while providing an impermeable barrier to prevent endoleaks and contrast blushing.Two Radiopaque Markers
Are made of platinum and allow for precise placement and positive visualization.TT DELIVERY SYSTEM Ergonomic No-Slip-Grip Handle
With innovative valve system for improved hemostasis.FlexiTip
With improved shape, flexibility, and radiopaque marker for visibility.Hydrophilic Coating
Aids in navigation of device through tight and tortuous anatomies by reducing friction with the artery wall.
More from MassDevice : LeMaitre wins conditional FDA nod for feasibility study...
Product page: TAArget Thoracic Stent Graft...
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Wednesday, November 25, 2009
3D Recon Turns CT Axial Images into Volumetric Visualizations
Medtronic has partnered with Vital Images out of Minnetonka, Minnesota to bring 3D reconstructions of CT images of abdominal and thoracic aorta, and other large vessels, to improve preoperative planning and operative outcome in patients that are undergoing for endovascular graft placements for treatment of aneurysms. Whether this partnership actually delivers clinically significant solutions, remains to be seen.
3D Recon is a new service from Medtronic that converts two-dimensional computed tomography (CT) axial images to three-dimensional images, offering advanced visualization of the anatomy and aneurysm measurement for device sizing. This technology allows physicians to streamline pre-case planning and patient follow-up. It is cleared by the U.S. Food and Drug Administration under a 510(k) granted to Vital Images.Vital Images is a leading provider of advanced visualization and analysis software. Its Endovascular Stent Planning application provides real-time automated clinical information specifically for the evaluation of abdominal and thoracic aortic aneurysms. The application enables removal of bone and anatomy from the image, visualization from the aortic root through the iliac bifurcation, as well as specific measurements for procedure planning. It allows vascular surgeons and interventionalists to instantly view three dimensional anatomy pre-operatively, followed by the implanted stent graft post-operatively.
Press release: Medtronic Introduces '3D Recon' Service to Enhance Endovascular Treatment of Aortic Aneurysms...
Vital's Vascular Imaging Solutions...
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Friday, November 20, 2009
Let Draeger Polaris Be Your Guiding Light
We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.
Details from the press release:
Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.
This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.
The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.
The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.
Press release: Precision lighting with the new Dräger Polaris...
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Monday, November 16, 2009
HeartWare Heart Pump Shows Positive Results in Clinical Study
HeartWare, a Framingham, Massachusetts maker of an innovative left ventricular assist system, released results of a European trial testing the survival rates in patients who've been implanted with the device. Just like other ventricular assist systems, HeartWare® is designed to provide a bridge to heart transplantation.
Our friends over at MassDevice report on the findings:
Data collected from a 50-patient trial aimed at winning CE Mark approval in the European Union (which was granted in January) showed a six-month survival rate of 90 percent, according to a regulatory filing. Two years after implantation the survival rate was 84 percent. Patients 60 years and older had a survival rate of 93 percent.The study also showed an 80 percent reduction in post-implantation re-hospitalizations in the 12 months after the procedure, compared with the 12 months preceding implantation.
More from MassDevice...
Link: HeartWare regulatory filings at the SEC...
Product page: HeartWare® Ventricular Assist System...
Flashback: Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD
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Thursday, November 12, 2009
FDA Grants Vascular Solutions Clearance for The GuideLine Catheter
US FDA has given 510(k) regulatory clearance to Vascular Solutions Inc., a 
Minneapolis, Minnesota firm, to market the GuideLiner™ catheter. The device, designed to provide a coaxial guide extension and rapid exchange for coronary or peripheral interventions, comes in 6F, 7F, 8F (Freedom Fries) sizes and is delivered through standard guide catheters, hence it allows physicians to use "standard length guidewires, balloons or stents through an existing hemostatic valve," according to the company.
From the press release:
The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”
Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”
Product brochure: GuideLiner Catheter...
Product page: GuideLiner Catheter ...
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Tuesday, November 10, 2009
A New LED Powered Endoscope from Schölly
Schölly Fiberoptic out of Denzlingen, Germany is releasing a new video bronchoscope with CMOS "chip-in-the-tip" and bright LED technology. The device is going to be unveiled at MEDICA 2009 next week in Düsseldorf.
The controller unit is plug-and-play with easy start-up. Its compact size saves table space and the simple controls eliminate the need for lengthy training. The controller is completely silent since it does not require a cooling fan. All video settings are preprogrammed, so no complicated and time consuming set-up is necessary. A single cable leads from the controller to the ergonomic handpiece. The handpiece includes the tip deflection lever, working channel port, suction valve, and buttons for taking photos and illumination adjustment. High-powered LEDs are incorporated inside the handpiece. These LEDs eliminate the need for costly replacement bulbs.
Link: Innovative New Video Bronchoscope with DeepVu Technology ...
(hat tip: German Healthcare Export Group)
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Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children
Cardiologists from Miami Children's Hospital, Morgan Stanley Children's Hospital, New York, and Children's Hospital Boston just published preliminary results from the study of Medtronic's Melody® Transcatheter Pulmonary Valve in 34 children and young adults who were implanted with the device for dysfunctional right ventricular outflow tract conduits. The early results are promising and may help the Melody valve get approved in the US as the first transcatheter cardiac valve on the market.
All patients underwent cardiac catheterization with the intention of implanting the artificial valve, and 30 of the 34 underwent actual implantation attempts, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.At follow-up six months later, no patient had more than mild pulmonary regurgitation. Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure, 19 had improved by at least one functional class at six months, and no patient's function had declined.
Eight of the 29 devices developed partial fractures during follow-up, and 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage.
Children's Hospital Boston press statement: Catheter-delivered Valve May Help People with Heart Defects Avoid Multiple Surgeries; Medtronic statement: Melody® Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease...
Abstract in Journal of the American College of Cardiology: Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit ...
Product page: Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System ...
Flashbacks: Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval ; Melody Transcatheter Pulmonary Valve Still Being Tested in the US ...; The Melody Valve Approved in Canada; The Melody Transcatheter Pulmonary Valve
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Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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