The newly approved Dynagen Mini and Inogen Mini implantable cardioverter defibrillators are the "world’s smallest and thinnest devices," according to a Boston Scientific press release. The devices are as much as 20% smaller by volume and nearly a quarter thinner than competing devices on the market, the company said.
Boston Scientific also won U.S. market approval for the Dynagen X4 and Inogen X4 quadripolar cardiac resynchronization therapy defibrillators, which offer 70% more pacing options and boast a 6-year warranty.
"With these new devices and our current line of long-lasting ICDs and CRT-Ds, including the world’s only subcutaneous ICD, we believe we offer the very best range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronization therapy," rhythm management president and executive vice president Joe Fitzgerald said in prepared remarks. "Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients."
It’s more good news for Boston Scientific, which just managed to overturn a ban on U.S. sales of its Guidezilla catheter. A federal appeals court this month overturned the ban, which was ordered late last year in a patent infringement lawsuit filed by Vascular Solutions (NSDQ:VASC).
Shares of Boston Scientific closed last night at $13.35, up 0.3% on the day. News of the latest FDA was announced after market close, spurring a 1.1% bump, with shares trading at $13.50 as of about 7:45 p.m. EST.
The company’s heart devices win came shortly after the FDA expanded the indication for some of Medtronic’s (NYSE:MDT) cardiac rhythm management devices to include bi-ventricular pacing in certain heart failure patients.