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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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.

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.

                                   Boston Scientific Corp. was given European CE Marking for its new ALTRUA family of pacemakers. ALTRUA pacemakers are used to treat bradycardia, a condition in which the heart beats too slowly. ALTRUA is flexible and features a sensor to regulate the heart after experiencing physical activity or emotional stress and an automatic capture capability designed for automatic and accurate ventricular pulse management.

Boston Scientific has received regulatory and reimbursement approvals from Japan for its Acuity Steerable heart failure lead. The company intends to launch the product in Japan immediately. After being implanted, the lead enables physicians to change the stimulation site in the heart without any invasion, the company said.

Boston Scientific Corp. has announced the commencement of the use of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (TM-ICD) by European doctors. Both these cardiac rhythm management devices received the CE Mark approval in January and are awaiting approval in the US. These are among the smallest and thinnest high-energy devices in the world and offer improved battery life and self-rectifying software.