Medical devices giant Boston Scientific (NYSE:BSX) this week won CE Mark approval in the European Union for updated labeling on several models of its implantable cardiac devices in recognition of battery life projections of up to 10 years in some cases.
European regulators allowed Boston Scientific to issue new labels with increased battery life projections for its Incepta, Energen, Punctua, Cognix and Teligen implants based on data submitted on each devices and its settings, according to a press release.
Boston Scientific has become something of a poster-child for ICD longevity, with group purchasing organization Novation earlier this year highlighting the company’s efforts to boost battery life as a must for all implantable device makers.
Longer battery life means fewer revision surgeries for patients, which ultimately means lower costs for health systems, according to Novation, whose purchasing scale includes 47% of all surgeries in the U.S.
"These new devices have the potential to dramatically reduce healthcare costs by cutting the number of expensive device change-out procedures in half," according to a Novation report issued in May. "Having fewer device change-outs benefits patients because there are fewer surgeries, resulting in lower costs as well as reduced risk of infections and complications from surgery."
The new longevity labeling for Boston Scientific’s implants exceed 10 years from some implantable cardioverter defibrillators and approach 8 years for the cardiac resynchronization therapy defibrillators, projections that double expectations of rival devices, according to a press release.
"Boston Scientific ICDs and CRT-Ds benefit from our proprietary advanced battery technology," Boston Scientific senior vice president and Europe, Middle East and Africa president Michael Onuscheck said in prepared remarks. "The new battery was first introduced in the Cognix and Teligen devices in 2008 and has now been incorporated into our newest devices. This European approval confirms the confidence already expressed earlier this year by the United Stated Food and Drug Administration."
The device maker in May announced FDA approval for updated longevity labeling for devices in the U.S. The new labeling effectively granted the devices the FDA’s stamp of approval for longevity, but Boston Scientific began offering extended warranties on some of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators in November 2011.
Standard implantable cardioverter defibrillators generally last up to 7 or 8 years, while CRT defibrillators may only last 5 years. A Medtronic (NYSE:MDT) product review found that less than half of all CRT-Ds released to market in 2007 were still in service after 4.4 years, according to Novation’s May report.
A new generation of Boston Scientific (NYSE:BSX) implants, however, boast an average 8-year life, with ICDs lasting as long as 10 to 12 years in projections, which could make a big difference for the ever-younger population of implant recipients.
The devices even won the commendation of highly regarded – and often controversial – Minneapolis Heart Institute cardiologist Dr. Robert Hauser.
"The excellent longevity of these devices combined with the length of the warranty has both clinical and financial implications for patients," Hauser said in a prepared statement issued late last year. "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."
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