Cardiac Surgery Archives

ClariTEE Miniaturized Transesophageal Echocardiography Probe and Zura System Receive EU CE Mark

by Wouter Stomp on Jul 20, 2011 •

rt2089v34 ClariTEE Miniaturized Transesophageal Echocardiography Probe and Zura System Receive EU CE MarkImaCor has received CE certification for its ClariTEE probe and Zura platform. The ClariTEE, which previously received FDA approval in 2008, is a miniaturized transesophageal echocardiography probe designed for continuous hemodynamic assessment of high-acuity patients in the peri-operative area or ICU for up to 72 t2rans probe 1 ClariTEE Miniaturized Transesophageal Echocardiography Probe and Zura System Receive EU CE Markhours.Traditional transesophageal echocardiography is not suitable for this application due to the large size of the probes and the prohibitive costs of dedicating one machine to one patient.

The ClariTEE is a disposable probe just the size of a nasogastric tube. The probe uses a highfrequency (7 MHz) for resolution combined with a 15 cm depth of penetration and is able to offer both color flow and B imaging modes.  It provides data about cardiac filling pressures, function and the presence of effusion or tamponade, and by obtaining serial views it can be used to monitor changes following administration of fluids or inotropic agents.

The video below shows the positioning of the probe and the views that are obtained:

Press release: ImaCor Receives CE Mark For ClariTEE Probe And Zura System…

Product page: ImaCor ClariTEE …

Flashback: ImaCor’s Disposable Transesophageal Echocardiography Probe and System Get FDA OK

Anesthesiology / Cardiac Surgery / Critical Care

World’s First Arm Cuff Monitor Measures Central Blood Pressure

by Gene Ostrovsky on Jul 19, 2011
World's First Arm Cuff Monitor Measures Central Blood Pressure

Centron Diagnostics, a spin-out of King’s College London, recently released a blood pressure monitor that can measure peripheral and central systolic blood pressure with one upper arm cuff.

The cBP 301 monitor not only records the waveform of blood pressure at the arm, but uses uses a transfer function to calculate the central blood pressure with accuracy similar to radial tonometry. According to the company, its technology has been validated against invasive measurements of central aortic blood pressure.

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Cardiac Surgery / Cardiology / in the news... / Radiology

BIOTRONIK’S New Single-Chamber ICD Detects Atrial Arrhythmias

by Gene Ostrovsky on Jun 27, 2011
BIOTRONIK'S New Single-Chamber ICD Detects Atrial Arrhythmias

BIOTRONIK has launched a new single-chamber implantable cardiac defibrillator and lead system. The Lumax 540 VR-T DX is capable of detecting atrial fibrillation in addition to traditional ventricular rhythm monitoring that other single-chamber ICD’s perform.  This is done thanks to the new Linoxsmart S DX ICD leads that feature a floating atrial dipole (side image) that can sense electrical activity in the atrium.  Like other BIOTRONIK implants, the new device is supported by the company’s HOME MONITORING system that will communicate any adverse events or detected conditions (like AF) straight to the physician.

More details about the new system from the press release:

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Cardiac Surgery / Cardiology / Radiology

St. Jude’s Unify CRT-D and Fortify ST ICD Make Their Way to Japan

by Smit Shah on Jun 23, 2011
St. Jude’s Unify CRT-D and Fortify ST ICD Make Their Way to Japan

St. Jude Medical’s Unify cardiac resynchronization therapy defibrillator (CRT-D) and Fortify ST implantable cardioverter defibrillator (ICD), which were FDA approved and CE Marked last year, have now been cleared for distribution in Japan. The Unify and Fortify are the smallest CRT-D and ICD on the market, which allows surgeons to use smaller incisions during implantation. The devices can also deliver more energy than existing options, and use SJM’s proprietary algorithms to monitor patients and reduce the likelihood of unnecessary shocks.

From the announcement:

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Cardiac Surgery / Cardiology / Radiology

SeptRx Launches European Testing of New Device to Treat PFO

by Smit Shah on Jun 17, 2011
SeptRx Launches European Testing of New Device to Treat PFO

SeptRx, Inc. of Fremont, CA has announced the start of the new InterSEPT clinical trial in Europe, which will provide additional safety and efficacy data about the company’s percutaneous transcatheter SeptRx Intrapocket PFO Occluder (IPO). The device is designed to repair patent foramen ovale (PFO) by bringing the septal surfaces together, without leaving much trace on both sides of the interatrial septum.  The IPO device performed favorably in an initial trial, and SeptRx plans to apply for CE Mark approval following this latest trial.

Some more specifics from the product page:

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Cardiac Surgery / Vascular Surgery

VASOSHIELD Pressure Controlling Syringe for CABGs to Go on Trial

by Gene Ostrovsky on Jun 14, 2011
VASOSHIELD Pressure Controlling Syringe for CABGs to Go on Trial


MAQUET is starting a trial of its VASOSHIELD Pressure Controlling Syringe, a device the company wants every cardiac surgeon to use to flush harvested saphenous veins to check for leaks before coronary artery bypass grafting.  A traditional syringe is typically used, which does not control the pressure of the liquid, often leading to tears within the intimal layer of the vessel.  The VASOSHIELD has three settings (150, 250, or 350 mm Hg) that specify the maximum pressure that will be applied.

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Cardiac Surgery / Cardiology / Radiology

St. Jude’s Portico Transcatheter Aortic Valve Implanted in Human (Exclusive Pics)

by Gene Ostrovsky on Jun 8, 2011
St. Jude's Portico Transcatheter Aortic Valve Implanted in Human (Exclusive Pics)

St. Jude Medical has just announced the first successful human implantation of the company’s Portico transcatheter aortic heart valve in a patient with aortic stenosis. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul’s Hospital in Vancouver, British Columbia. We hear that St.Jude is working hard to make sure the device is safe and secure, so things like perivalvular leaks and valve displacements do not happen during or after implantation. Furthermore, the company is looking into ways to develop both transapical and transfemoral deliveries for the valve. And, in addition, the device, when it is finally approved, might feature the company’s proprietary Linx anticalcification technology that might actually prolong the life of the device and/or prevent calcium buildup and things like embolizations.

Check our exclusive images of the device, and here’s more info about it from the announcement:

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Cardiac Surgery / Cardiology

ACT’s TEMPASURE for Atrial Arrhythmias Wins European Approval

by Gene Ostrovsky on Jun 8, 2011
ACT’s TEMPASURE for Atrial Arrhythmias Wins European Approval

Advanced Cardiac Therapeutics, Inc. has received the European CE Mark for its TEMPASURE cardiac ablation catheter.  The device is capable of measuring local temperature of the treatment area, helping prevent overheating, while delivering saline irrigation.

The TEMPASURE system is designed to result in better outcomes for patients by reducing overall procedure time and increasing therapeutic effectiveness, while avoiding rare but serious adverse events that can occur with current technologies. The system’s novel passive sensing microwave radiometry technology allows the electrophysiologist to measure the temperature of cardiac tissue during the ablation procedure, providing real-time information that enables proper energy delivery and lesion control. This technology is designed to allow, for the first time, safe and effective automatic RF power titration or “Temperature Mode” irrigated ablation.

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Cardiac Surgery / Cardiology

BIOTRONIK’s Orsiro Hybrid DES Performs Well in Human Trial

by Gene Ostrovsky on Jun 2, 2011
BIOTRONIK's Orsiro Hybrid DES Performs Well in Human Trial

At a recently concluded EuroPCR 2011 Congress in Paris, France, researchers presented results from the first in man trial of BIOTRONIK’s Orsiro Hybrid Drug-Eluting Stent. This is the company’s up and coming solution that combines two different types of coating: one that does not elicit body response to the implant, and the other one that features a bioabsorbable matrix with a slow-release limus drug.

BIOTRONIK’s product description:

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