Boston Scientific (NYSE:BSX) today announced that the FDA approved revised labeling for a handful of its cardiac rhythm management devices to reflect that some may last as long as 10 years before requiring replacement.
The new labeling effectively grants 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.
The federal watchdog agency granted new longevity labels for certain of the Natick, Mass.-based device maker’s CRM implants based on projections that the ICDs may last more than a decade and the CRT-Ds may go for nearly 8 years – projections that double those of competing implants, according to a press release.
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."
Certain ICDs lasted an average of 11 years in a recent Sudden Cardiac Death in Heart Failure Trial’s long-term follow-up, with particularly long-lasting results in patients with Class II heart failure, according to the company.
"By helping to mitigate the frequency of replacing an ICD or CRT-D device, this technology provides us with the potential to reduce the complications associated with replacement procedures and to reduce healthcare costs," University of Washington Medical Center electrophysiologist Dr. Jeanne Poole said in prepared remarks. "Not only does the patient benefit from fewer surgeries, but the financial benefit can be significant."
Boston Scientific was recently touted as a model for fellow device makers in developing CRM implant battery technology that boosts an implant’s lifetime, and thereby reduces patients discomfort and ongoing costs of replacement during a patient’s lifetime.
Devices lasting 7 to 9 years could cut direct costs by $190 million and $296 million over 15 years, according to a study conducted by at the Cleveland Dept. of Veterans Affairs Hospital in 2005.
"In light of the trend toward earlier intervention, the increasing number of younger ICD/CRT-D patients, and average U.S. life expectancy of 76 years for men and 81 years for women, the average patient could expect to receive 2 to 4 device change-outs over their lifetime," according to a report from group purchasing organization Novation. "Data from the ICD registry estimate procedure and device replacement cost is about $37,000, not including physician or anesthesia fees. Six ICD surgeries over this patient’s lifetime could therefore easily exceed $220,000, a portion of which would be out-of-pocket expenses for the patient, who also must endure the 6 procedures."
The company’s Incepta and Energen VR ICDs are now labelled for 10 years, Incepta & Energen DR ICDs for 8, Punctua and Teligen ICDs for 7, Incepta and Energen CRT-Ds for 6 and Punctua and Cognis CRT-Ds for 5 years, according to a press release.
"Novation commends manufacturers like Boston Scientific for continuing to develop longer-lasting and enhanced therapy devices," Novation concluded. "We challenge CRM manufacturers not only to extend their warranty life, but also to change their pro-rated warranties and offer full warranties with minimum coverage of 5 years."