Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Incepta, Energen and Punctua cardiac implants to treat heart failure and sudden cardiac death.
To go along with the new defibrillator systems, the Natick, Mass.-based med-tech titan is providing an extended warranty for the Incepta and Energen family of defibrillators.
BSX is providing extended warranties for up to 10 years, depending on the defibrillator model. The warranties are five years longer than those for devices currently on the market, according to the company.
Energen and Incepta VR implanted cardioverter defibrillators are covered with a 10 year warranty, the Energen and Incepta DR ICDs are covered for eight years and the company’s cardiac resynchronization therapy defibrillators are covered for six years.
The majority of patients with cardiovascular problems who receive ICDs live more than seven years after surgery, according to the company. Some patients live for decades after implantation.
"The excellent longevity of these devices combined with the length of the warranty has both clinical and financial implications for patients," Robert Hauser of the Minneapolis Heart Institute said in prepared remarks. "Greater longevity potentially reduces the number of implant surgeries, which minimizes complication risk and helps improve patient outcomes. The warranty also reduces out-of-pocket expenses for patients as well as healthcare system costs."
The devices boast an extended battery life, enhanced therapy options, a universal connector system and the industry’s smallest and thinnest profile, according to Boston Scientific.
"These devices are a direct response to what patients tell us they want the most — small, thin, long-lasting devices that provide appropriate therapy when necessary," said University of Washington Medical Center professor Dr. Jeanne Poole, who implanted the first Incepta ICD in a patient yesterday.
The trio won CE Mark approval in the European Union in November of last year.
Pre-market trading drove BSX stock up 2.5 percent to $5.69 opening on Wall Street today. BSX shares closed yesterday at $5.55.
The medical device giant has been getting good news from the federal watchdog agency lately, with the approval of its Promus Element drug-eluting stent last week.
Shares rose nearly 7 percent in pre-market trading after the FDA approved Boston Scientific’s Promus Element drug-eluting stent, inaugurating a head-to-head battle between two of the last giants left standing in the Stent Wars.
The Promus Element is BSX’s platinum-chromium iteration of an everolimus-eluting stent like the original Promus, a private-label version of Abbott’s (NYSE:ABT) Xience V device. The private-label deal ended in 2009 and each company began developing their own next-generation designs.
The FDA approved Abbott’s Xience Prime, a cobalt-chromium alloy design, earlier this month. Both companies’ stents elute the drug everolimus.
The Promus Element approval came despite an FDA probe into reports that the Element’s thinner design is prone to longitudinal deformation.
Neuros Medical Inc. received an Investigational Device Exemption approval from the FDA, allowing it to commence a pilot clinical trial to evaluate the company’s patented high frequency Electrical Nerve Block technology for use in acute treatment of pain in the residual limb of amputees.
MMAtech Ltd., developer of components for orthopedic implants, won CE Mark approval in the European Union for its new acetabular liner implant.
STAAR Surgical Company (NSDQ:STAA), developer of minimally invasive refractive lenses, announced that its Visian Toric implantable collamer lens has been approved by the Japanese Ministry of Health, Labor & Welfare.
SweetSpot Diabetes Care Inc. received 510(k) clearance from the FDA for the SweetSpot Diabetes Data Management Service, which helps health care providers and patients see, understand and use blood glucose meter data to diagnose and manage diabetes.
Cytori’s (NSDQ: CYTX) Celution One System, the next-generation device of the company’s Celution platform, won CE Mark approval. The Celution platform is a GMP-compliant technology that extracts and concentrates a patient’s own stem and progenitor cells from adipose (fat) at the point-of-care.
GE Healthcare (NYSE:GE) won FDA clearance for its Centricity Radiology mobile access platform, which enables radiologists to use their iPad and iPhone devices to remotely diagnose select patient images from Centricity PACS.
Royal Philips Electronics (NYSE:PHG) won 510(k) clearance from the FDA for the company’s first commercially available whole body positron emission tomography/magnetic resonance imaging system, the Ingenuity TF PET/MR.
Cynosure Inc. (NSDQ: CYNO) received market approval from the Korea Food & Drug Administration for its Cellulaze Cellulite Laser Workstation.
W. L. Gore & Associates Inc. received FDA approval for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore(R) Excluder(R) AAA endoprosthesis for treatment of abdominal aortic aneurysm.