Boston Scientific gets FDA nod for long-life cardiac implant

FDA
Boston Scientific thinks its Resonate devices will increase interest in multipoint pacing

Boston Scientific has received FDA approval for its Resonate line of high-voltage cardiac devices. The regulatory nod clears Boston Scientific to start selling devices it thinks can overcome reticence among physicians to use multipoint pacing products by diminishing concerns about battery life.

FDA gave its approval to Boston Scientific’s Resonate line of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator (CRT-D) systems. The products all use the EnduraLife battery, a technology Boston Scientific claims has twice the capacity as that used by Medtronic in its Evera XT VR DVBB2D4 device. Boston Scientific has made battery life the centerpiece of its push to sell Resonate devices in Europe.

“While the battery longevity of our competitors' products often limit physician appetite for program multipoint pacing due to the associated battery drain, we have seen strong early European adoption in our Resonate launch,” Boston Scientific CEO Michael Mahoney said on a call with investors last month.

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Mahoney attributed interest in the devices since they received a CE mark in February to the fact the EnduraLife battery makes it feasible to program multipoint pacing at implantation. Multipoint pacing enables physicians to optimize CRT to each patient, cutting the number of nonresponders. Boston Scientific is now set to take the value proposition that has underpinned its marketing in the European Union to the U.S.

The company’s pitch is backed up by an independent analysis. In March, U.K. cost watchdog NICE released guidance on EnduraLife-powered CRT-Ds that reviewed retrospective studies comparing the battery life of devices from Boston Scientific, Medtronic and St. Jude Medical. NICE’s conclusions largely backed up Boston Scientific’s pitch.

“The published studies demonstrate that EnduraLife-powered CRT-Ds implanted between 2008 and 2010 lasted longer than other CRT-Ds implanted during the same period. However, some of the CRT-Ds in these studies, particularly the comparator devices, are no longer marketed,” NICE wrote.

That last sentence hints at the challenge facing Boston Scientific. While the studies show Boston Scientific took an early lead in battery life, its competitors have fought back with new products. Boston Scientific’s first-mover status means its battery-life claims have already been reviewed by NICE, though. And, according to experts consulted by NICE, EnduraLife still has one of the largest ampere hours ratings, a key measure of battery life.

Such longevity makes multipoint pacing easier for physicians to justify and reduces the need to replace devices. NICE put the cost of replacing a CRT-D device at up to $19,000, not including the outlay on additional leads, and heard evidence of the small but real risk of major complications from the procedure.

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