Incepta, Energen and Punctua
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.
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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.
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