A Food and Drug Administration panel unanimously voted for broader use of Boston Scientific’s cardiac resynchronization therapy defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms.

CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also benefit healthier patients.

However, the panel said that the use of the devices should only pertain to patients who have a heart problem that causes the left ventricle to contract later than the right ventricle.

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The Food and Drug Administration has approved Medtronic Inc’s heart valve that can be implanted without open-heart surgery. Known as the Melody transcatheter pulmonary valve, the device is designed to be implanted through a small catheter inserted into the patient’s body. It replaces the pulmonary valve in patients born with a heart defect. It is the first heart valve approved for sale in the US that can be implanted without open-heart surgery.

The federal Food and Drug Administration has approved a continuous-flow heart-assist device pioneered at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) for use as a permanent treatment for advanced heart failure. The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States.

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HeartWare International Inc. took another step in its chase after one-time suitor and main competitor Thoratec Corp. filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren’t eligible for a heart transplant. The Framingham, Mass.-based device maker’s left ventricular assist device is already cleared for use as a bridge to heart transplant.

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Medtronic Inc has confirmed that it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company’s largest unit. The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.

Onset Medical Corporation has announced that it has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter. These catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Another clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treating aortic aneurysms.

Vascular Solutions, Inc. has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the GuideLiner(TM) catheter. 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.

Biosense Webster, Inc. has announced that FDA has cleared for marketing the CARTO® 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms. Atrial Fibrillation, or AFib as it`s more commonly known, is the most prevalent cardiac arrhythmia affecting between 2.3 to 5.6 million adults in the country and is the leading cause of stroke among people 65 years and older.

Boston Scientific Corp has received approval from the FDA to market its new WallFlex Biliary RX covered stents. The stents are designed to treat clogged bile ducts in cancer patients. The liver excretes bile, which the body uses to help digest food. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. The new covered version of the stents was also approved by European regulators.

The FDA approves Boehringer Ingelheim’s MICARDIS® (telmisartan) as the first treatment in its class to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients at high cardiovascular risk who are unable to take ACE inhibitors. This new indication is based on The ONTARGET Trial results which showed that MICARDIS® may prevent one in five serious CV events or death from cardiac causes.