A new contestant in the $115-million global heart valve repair market, the ATS Simulus annuloplasty line of products by ATS Medical was cleared for release by the FDA at the end of January. Designed with input from cardiac surgeons, the devices emphasize ease of implantation.
Available in a flexible ring (the ATS Simulus FLX-O Ring) or a flexible band (the ATS Simulus FLX-C Band), the products accommodate various approaches to valve repair. They can be used in both the mitral and tricuspid position.

The FDA has approved revised labeling for the instructions for use of the CYPHER Sirolimus-eluting Coronary Stent. The labeling now reflects FDA's review of clinical trial data that suggests there is no increased risk of myocardial infarction with the use of overlapping CYPHER Stents in comparison to bare metal stents.
The change is based on a retrospective analysis of several clinical studies of overlapping CYPHER Stents examining more than 900 patients. Cypher is the only drug-eluting stent with this new label.

A new percutaneous transluminal angioplasty balloon catheter, the Advance ATB PTA Dilatation Catheter by Cook is designed for optimal ease of insertion and pullback into the sheath.
Responding to the needs of physicians performing numerous dilatation procedures, the Advance balloon incorporates an increased lumen size for faster inflation/deflation rates while still providing sufficient rated burst pressure to dilate demanding lesions.

The Elecsys proBNP assay is the first and only natriuretic peptide test to receive FDA clearance for the risk assessment of cardiac events in people who have stable coronary artery disease — nearly 13 million in the U.S.

Better cardiac diagnosis and fewer hospitalizations are the promise with newly FDA-cleared CardiArc, a SPECT imaging device that will give physicians sharper images of blood flow and function of their patients hearts — in half the time previously required.
Offered by CardiArc Ltd., the patented, smaller and faster technology for cardiac single photon emission computed tomography (SPECT) has twice the resolution of existing devices. The system is as small as an executive chair, runs on 110 Volts AC and fits easily in a 6 by 7 foot exam room without remodeling.

Enabling the TandemHeart percutaneous ventricular assist device to provide blood flow of up to five liters per minute, the TandemHeart Transseptal Cannula – Enhanced Flow (THTC-EF) from CardiacAssist is positioned in the left atrium.

HeartSuite is a suite of integrated, enterprise cardiology tools that offer cardiovascular information management, hemodynamic monitoring, advanced visualization and content management.
Emageon’s Enterprise Visual Medical System (EVMS) combines HeartSuite with radiology and other medical specialties for a comprehensive patient-centric view of the visual medical record.

With a high performance portable ultrasound design, the echo Ultrasound System provides unique advantages in the field of echocardiography. The system provides high- quality spatial resolution, high frame rates and sensitive Doppler performance. Based on Terason's Teratech Architecture, the system delivers a portable color doppler imaging platform without sacrificing clinical performance.

The Innova 3131IQ and 2121IQ digital flat panel biplane imaging systems cover the full size of the patient’s lateral and frontal anatomy simultaneously for a variety of cardiovascular and neurovascular image guided interventional procedures. 
With the systems, procedures can be done with fewer X-ray images and contrast injections. Both systems are indicated for use in cardiovascular imaging, diagnostic and interventional procedures and three-dimensional imaging of vessels and soft tissue.

The SpideRX Embolic Protection Device, by ev3 Inc., features the ability to use a separate, preferred guidewire to cross the lesion and a preloaded nitinol filter with a dual-ended catheter for delivery and recovery. Offering a fully rapid exchange system, the SpideRX Device is easy to use in the indicated applications.

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