Biotronik wins FDA approval for next-gen ICD and CRT-D

The competition to gain market share with next-generation ICD and CRT-D just got tougher. German device giant Biotronik won FDA regulatory approval for its new Lumax 740 implantable cardioverter defibrillators and cardiac resynchronization therapy devices.

Approval is great and all. But Biotronik faces significant competition, particularly in the U.S. market from stalwarts including, Boston Scientific ($BSX), Medtronic ($MDT) and St. Jude Medical ($STJ), as each tries to boost declining ICD and cardiac rhythm management division sales. St. Jude Medical just announced earlier this week that it gained FDA approval for its new tiny Ellipse implantable ICD (also designed to reduce bad shocks and generate more data). And Cameron Health isn't far behind, thanks to a big FDA panel recommendation to approve its first-in-the-U.S., under-the-skin implantable defibrillator that some are heralding as "breakthrough technology." With Cameron, Boston Scientific will gain by default, once it finalizes its $150 million bid for the company.

Perhaps the details will be key here. Biotronik touts its devices, which also have their CE mark, as being able to generate more data to help manage heart failure as the disease progresses and also reduce unnecessary shocks. The company also claims the implants are more durable and will last up to 15 months longer (almost a decade-plus now) "under demanding conditions." What's more, the company said the device will work with a next-generation home monitoring system that will help detect problems early.

Of course, competition is good. But it will be interesting to see who wins, and who loses the race.

- here's the release

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