Archives: 5/2009

dfs342113 Cook Med Releases Antibacterial Spectrum Turbo Ject PICC Line
Cook Medical has released a new FDA approved venous catheter for pressure injection of CT contrast media. To prevent the occurrence of catheter-related bloodstream infections (CRBSIs), the treatment of which is no longer Medicare reimbursed, the catheter is coated with Spectrum, a proprietary formulation comprising the antibiotics minocycline and rifampin.
From the press release:

With the Spectrum Turbo-Ject PICC, clinicians can choose from multiple catheter configurations that offer an industry-best range of flow rates in order to meet patient needs, including:

  • Maximum pressure limit settings of 325 psi
  • 5 French single and double lumen with a maximum flow rate of 7 and 5 mL/second, respectively
  • 4 French single lumen with a maximum flow rate of 4 mL/second
  • 50 cm and 60 cm length available
  • Spectrum technology has been shown to establish zones of inhibition greater than 15 mm for up to 63 days against the leading cause of CRBSIs.
    The combination of the antibiotics minocycline and rifampin that are impregnated within the material of the Cook Spectrum catheters work synergistically to provide broad-spectrum protection against gram positive, gram negative and fungal organisms in both short- and long-term use. Unlike most systemic antibiotics, this unique combination has the ability to penetrate the biofilm that forms on all indwelling catheters. Additionally, research has conclusively shown that use of these catheters does not promote the growth of antibiotic-resistant strains of bacteria in patients receiving Spectrum catheters. In fact, the use of Spectrum technology has demonstrated reduced antibiotic-resistant strains in on single-center study.
    The Cook Spectrum Turbo-Ject PICC will be complimented by the PICC Procedural Tray, designed to efficiently supply the essential components for a clinician placing a PICC, whether bedside or in an interventional radiology lab. The tray provides the vital components for maximal sterile barrier precautions, a significant part of patient safety and infection control.

    Press release: Cook Medical Launches Industry-First Pressure Injection Peripherally Inserted Catheter with Antibiotic Protection to Prevent Potentially Fatal Infections

    TedMEDlogo TEDMED. Well Be There. Were Excited.Medgadget is thrilled to announce that a couple of your editors will be attending and covering TEDMED this October 27-30th on the beautiful Coronado Island, off the coast of San Diego. If you’ve not heard about TEDMED already, it’s pretty much the ultimate conference for those interested in medical advances. Created by Marc Hodosh (from the Archon X PRIZE for Genomics) in partnership with Richard Saul Wurman (TED founder), the forum is short speeches with plenty of time for networking in order to, according to their website, “celebrate conversations that demonstrate the intersection and connection between all things medical and healthcare related.” Speakers include the likes of Dean Kamen, Craig Venter, Sanjay Gupta, Anne Wojcicki, and more.
    TedMed%20Speakers TEDMED. Well Be There. Were Excited.
    Registration is open for those of you who’d like to join in on the fun (keep in mind that there’s only 400 spots). Also, we’ll be strategically planning our coverage of the conference so if you’ve got any ideas or see any speakers you’re particularly interested in, let us know.
    To say that we’re counting down the days would be an understatement.
    Link: TEDMED…

    346534hoop NEJM Unveils H1N1 Influenza Information Center
    Rapid delivery of relevant medical information is important during an epidemic, or even during a baseless panic. The New England Journal of Medicine has setup a website specifically dedicated to the H1N1 virus, formerly known as swine flu, providing full and free access to articles and features relevant to practitioners, researchers, and the public.
    Link: NEJM H1N1 Influenza Center
    (hat tip: Dana Blankenhorn)

    cur3424423 SJM Gets FDA OK for New AICDs
    St. Jude Medical is reporting that it has received FDA approval for two of the company’s latest cardiac defibrillators, the Promote Plus cardiac resynchronization therapy defibrillator and Current Plus implantable cardioverter defibrillator. Both models have wireless reporting capabilities and SJM says they should prove to be more comfortable for the patients.
    From the press release:

    To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the Promote Plus CRT-D and Current Plus ICDs also include a new atrial tachycardia/atrial fibrillation (AT/AF) Alert feature. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value and occurs over an extended time period. These devices can also be programmed to notify the patient through a unique vibratory alert that has been clinically proven more effective than audible alerts.1 Additionally, the devices have the ability to inform the patient’s clinic through the St. Jude Medical Merlin@home® transmitter and Merlin.net™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF.
    The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude Medical consolidated hardware and software “Unity” device platform and include the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.
    TailoredTherapy features in these devices include:
    * QuickOpt® timing cycle optimization – a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds, CRT-Ps (cardiac resynchronization therapy pacemakers) and ICDs to help physicians quickly program the device’s timing cycles – in about 90 seconds – to help deliver optimal therapy to patients
    * DeFT Response® technology – designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy
    * VIP® (Ventricular Intrinsic Preference) algorithm – provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient’s own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients’ overall heart health.
    * SenseAbility® technology – designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks

    Press release: St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices to Provide Therapy for Life-Threatening Arrhythmias and Heart Failure

  • Latina Moms Cite Family’s Health As A Top Concern, Yet Time Pressures Are Their Number One Challenge, A New SPLENDA® Brand Survey Reveals… [Johnson&Johnson]
  • Covidien Announces Definitive Agreement to Acquire VNUS Medical Technologies, Inc…. [Covidien]
  • Another Potential Plavix Competitor: AstraZeneca’s Brilinta… [WSJ]
  • Despite Recession, Personalized Health Care Remains in Demand… [NYT]
  • Hot on the trail of swine flu at Harvard… [Boston.com]
  • Journal of American College of Cardiology Article Reports Fewer Repeat Procedures With Boston Scientific’s TAXUS® Liberte® Stent… [Boston Scientific]
  • FDA Approves Drug for Treatment of Aggressive Brain Cancer… [FDA]
  • Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study) [BMJ]
  • Researchers Uncover Genetic Clues to Blood Pressure… [NIH]
  • Next generation oncology drug development: opportunities and challenges… [Nature Reviews Clinical Oncology]
  • Relax and Learn: New Drugs that Help DNA Unwind May Improve Memory… [HHMI]
  • Ischemic postconditioning as a novel avenue to protect against brain injury after stroke… [Journal of Cerebral Blood Flow & Metabolism]
  • Research says older people need more sun… [University of Warwick]
  • What Is ‘Socialized Medicine’?: A Taxonomy of Health Care Systems… [NYT]
  • jjda3432 Edwards Announces New Cardiac OfferingsEdwards Lifesciences won FDA approval for its new Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, and is also introducing the PORT ACCESS EndoDirect surgery system for minimally invasive cardiac procedures.
    Features of the Magna Ease valve from Edwards’ EU product page:

  • Low profile facilitates insertion and provides sinotubular junction clearance
  • Low cusp height maximizes coronary ostia clearance
  • Suture markers aid in valve orientation and suture placement
  • Scalloped and compliant sewing ring provides an optimal anatomic fit
  • Compact sewing ring maximizes valve orifice area
  • Industry-leading effective orifice areas (EOAs) and low gradients documented in multiple published studies
  • Magna Ease heart valves include leaflets treated with the Carpentier-Edwards ThermaFix process*—the only dual-action tissue treatment designed to confront both major calcium binding sites
  • Built on the proven performance of PERIMOUNT aortic valves, with durability up to 20 years
  • awe23423 Edwards Announces New Cardiac Offerings
    About the PORT ACCESS EndoDirect System from the press release:

    Edwards is introducing the PORT ACCESS EndoDirect System, which allows cardiac surgeons to stop a patient’s heart and keep it at rest for the duration of the heart valve procedure without an incision down the middle of the chest. In procedures such as mitral valve repair and replacement, the EndoDirect System provides a minimally invasive alternative for direct aortic cannulation when femoral access (groin cannulation) is not an option.

    Company animation describing the Magna Ease and comparing it to the Magna model:


    Link to video of the Magna Ease implantation performed at the University Hospital of Wales…
    Press release: Edwards Lifesciences Receives FDA Approval for New Heart Valve
    Edwards EU product page: PERIMOUNT Magna Ease Aortic Heart Valve
    Flashback: Edwards PERIMOUNT Magna Mitral Valve Gets FDA’s Green Light

    dier234234 Lab on a Tube for Multimodality Neuromonitoring Post Brain InjuryUnderstanding the state of the intracranial environment is important in patients following traumatic brain injury. Researchers at the University of Cincinnati have created a “lab-on-a-tube” device that can drain cerebrospinal fluid (CSF) while monitoring the pressure, oxygen content, temperature, and glucose within the intracranial space. The researchers describe the new device that uses sensors wrapped into a helix in the March 20th issue of Lab on a Chip.
    From the paper:
    sid3342234 Lab on a Tube for Multimodality Neuromonitoring Post Brain Injury

    The new LOT offers numerous advantages over existing approaches: (a) only one hole is needed to place the LOT, hence it is less invasive; (b) the diameter of the LOT can be contracted or expanded to safely lie within intracranial and intravascular locations, thus minimizing the potential trauma associated with existing technologies; (c) the use of a single device is less expensive and less complicated when compared with the use of multiple individual sensors; (d) the LOT can provide both focal (brain tissue) and global (CSF/blood) information, which is an improvement over the cerebral microdialysis (MD) technique that is limited to focal neurochemical information;3,4 and (e) the buried spirally-rolled microchannels can not only deliver in vivo calibration solution for the biosensors, but also allow convection-enhanced and targeted drug delivery to be realized.

    cent323423 Lab on a Tube for Multimodality Neuromonitoring Post Brain Injury
    Full article in Lab on a Chip: A novel lab-on-a-tube for multimodality neuromonitoring of patients with traumatic brain injury (TBI)
    Images: Side 2: Conceptual drawing of a novel lab-on-a-tube for multimodal neuromonitoring of patients with traumatic brain injury. The lab-on-a-tube can measure pressure, oxygen, temperature and glucose information as well as drain CSF simultaneously.; Side 2: Schematic drawing of LOT. PVDF-TrFE film with pressure sensor, Kapton film with glucose, oxygen and temperature sensors, and parylene microchannels were stacked, bonded and rolled spirally to form a tube. Center: Photographs of fabricated devices: LOT (ID = 1.5 mm; OD = 1.7 mm) is anchored through customized bolted ventricular and connected to LabView monitoring system and CSF drainage bag.
    (hat tip: gizmag)

    cart x220 Stem Cells and Nanoscaffolds May Serve as Replacement for Damaged CartilageDamaged cartilage of large bones, as in osteoarthritis, is a particularly common condition in humans, especially as we age. Now there’s hope that cartilage grafts may be possible thanks to fiber scaffolds with nano scale features.
    From the MIT press office:

    The scaffold has two layers, one that mimics bone and one that mimics cartilage. When implanted into a joint, the scaffold can stimulate mesenchymal stem cells in the bone marrow to produce new bone and cartilage. The technology is currently limited to small defects, using scaffolds roughly 8 mm in diameter.
    The researchers demonstrated the scaffold’s effectiveness in a 16-week study involving goats. In that study, the scaffold successfully stimulated bone and cartilage growth after being implanted in the goats’ knees.
    The project, a collaboration enabled by the Cambridge-MIT Institute, began when the team decided to build a scaffold for bone growth. They started with an existing method to produce a skin scaffold, made of collagen (from bovine tendon) and glycosaminoglycan, a long polysaccharide chain. To mimic the structure of bone, they developed a technique to mineralize the collagen scaffold by adding sources of calcium and phosphate.
    Once that was done, the team decided to try to create a two-layer scaffold to regenerate both bone and cartilage (known as an osteochondral scaffold). Their method produces two layers with a gradual transition between the bone and cartilage layers.
    “We tried to design it so it’s similar to the transition in the body. That’s one of the unique things about it,” said Gibson [Professor Lorna Gibson, co-leader of the MIT research team -ed.].
    There are currently a few different ways to treat cartilage injuries, including stimulating the bone marrow to release stem cells by drilling a hole through the cartilage into the bone; transplanting cartilage and the underlying bone from another, less highly loaded part of the joint; or removing cartilage cells from the body, stimulating them to grow in the lab and re-implanting them.
    The new scaffold could offer a more effective, less expensive, easier and less painful substitute for those therapies, said Gibson.

    Chondromimetic technology @ OrthoMimetics…
    More from MIT Technology Review
    Image: Mesenchymal stem cells (labeled green) are grown on a scaffold of nanofibers (labeled red). Credit: Casey Korecki, Caren Aronin, and Rocky Tuan

    annuring SJM Gets US Green Light for Adjustable Annuloplasty RingThe FDA has given St. Jude Medical approval for the Attune Flexible Adjustable Annuloplasty Ring. Indicated for patients with mitral regurg, the product’s unique adjustable design should let the surgeon perform a tighter, more precise fitting.
    From the press release:

    Unlike most other flexible annuloplasty rings that have a fixed size, the Attune ring can be adjusted after it is sutured to the annulus — a feature that allows physicians greater control in altering its size and shape to contribute to a more refined repair specific to fit each patient’s heart valve anatomy. The Attune ring is suitable for repairs performed with open chest, minimally invasive or robotic surgical approaches.
    The ring’s flexibility allows the annulus to continue its natural movement as the valve opens and closes, thus contributing to more physiologic valve function. The ability to adjust the ring post-implant promotes ideal leaflet alignment to reduce or eliminate residual regurgitation, or small leaks after the repair.

    Press release: St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair