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.

Boston Scientific Corporation has announced that it has received CE Mark for its PROMUS® Element(TM) Everolimus-Eluting Coronary Stent System, the Company’s third-generation drug-eluting stent (DES) technology. The PROMUS Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. The Company will begin marketing the PROMUS Element system immediately in the European Union and other CE Mark countries.

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.

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 announced that roughly 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable. Although there have been reports of the memory chips in some of the defibrillators failing during routine self tests, none of them have failed during emergencies and caused patient injuries or deaths.

The Johnson & Johnson subsidiary, Cordis, wins a nod from the FDA for its 2.25mm Cypher drug-eluting stent for treating blockages in small blood vessels. The company said data from the RESEARCH and T-SEARCH studies indicated that patients treated with the small Cypher model had a 65% lower incidence of death or heart attack than patients treated with the 2.25mm Boston Scientific device.

Zoll Medical Corp received the FDA marketing approval for a new model of its LifeVest wearable defibrillator. The LifeVest is worn by patients who are at a risk of sudden cardiac arrest. Zoll said more than 2,000 patients are currently using the product. The company aims to increase its inventory to support further growth.

Angiotech Pharmaceuticals Inc and Cook Medical’s Zilver PTX drug-coated stent has received approval for use in the European Union (EU). The device is used to prevent blockage of the superficial femoral artery, which is the main blood vessel in the thigh. The use of the stent has already started in patients.

St. Jude Medical Inc has received approval from the US Food and Drug Administration (FDA) for a pair of wireless-ready pacemakers called the Accent RF pacemaker and Anthem RF CRT-P (for cardiac resynchronization therapy pacemakers). These pacemakers can wirelessly communicate with a programmer used by the clinician or a home monitor.

Boston Scientific has received the FDA approval to market its Taxus Liberte long paclitaxel-eluting coronary stent system, a next-generation drug-eluting stent designed for long lesions. At 38mm, Taxus Liberte long stent is the longest available drug-eluting stent (DES). This provides doctors with an option that can potentially reduce the number of stents used in more complex cases, simplifying procedures and reducing costs. The company plans to launch the product in the US in August.