Tuesday, after the bell, Boston Scientific Corp. (BSX), engaged in the development, manufacture and marketing of medical devices used in cardiovascular, endosurgery and neuromodulation specialties, announced that the U.S Food and Drug Administration or the FDA, has granted approval for two new devices which will be used for treating heart failure and sudden cardiac death.
The Natick, Massachusetts-based company stated the two products, which were granted approval by the FDA, are COGNIS cardiac resynchronization therapy defibrillator, or CRD-T, and TELIGEN implantable cardioverter defibrillator, or ICD.
The company further noted that the two new products, COGNIS CRT-D and TELIGEN ICD, are among the world's thinnest and smallest high energy devices at 32.5 cc and 31.5 cc respectively. The thickness of each of the devices is less than 10 millimetres. In addition to being the smallest and thinnest energy devices, the new products have features that are based on latest technological advances, which includes, among others, self-correcting software, improved programming technology as well as extended battery longevity.
Boston Scientific stated that the new products represent entirely new platforms for treatment of heart failure and/or sudden cardiac death. The new devices, which are the results of strenuous research and development efforts taken up over the past few years, are expected to provide enhanced options for treatment by the physicians.
The company also added that the new products, which are built on totally new platforms, have an programming interface and necessary hardware and software components. The other important feature of the devices is that each of these devices offer a redundant hardware system, which provides lifesaving shock therapy as well as basic pacing functionality, in the unlikely event of a system error in the midst of an operation or diagnosis.
While commenting on the results, Jim Tobin, President and Chief Executive Officer of the company said, "COGNIS and TELIGEN are truly breakthrough technologies featuring significant engineering advances. These products are testaments to the revitalization of our CRM business and strong product pipeline. With more than 10 worldwide regulatory approvals since the beginning of the year and several others planned, we are delivering enhanced therapy systems designed to meet clinician needs for safety, reliability and better patient outcomes."
The stock price of BSX closed the regular trading session on Tuesday at $13.01, down 2.98%, or 40 cents, on a volume of 10.9 million shares. In the after-hours trading, following the release of the latest information, the stock price moved up smartly by 21 cents or 1.61%.
For comments and feedback: editorial@rttnews.com