Germany's Biotronik won the FDA's sign-off for its Ilesto line of cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D).
The company is already taking competitive punches, touting the line as offering "smaller, thinner and lighter" devices than the competition. They also come with the company's Ilesto Dx home monitoring, which is designed to allow physicians to collect data and spot atrial fibrillation they may have otherwise missed. In addition, Ilesto relies on a single lead, the company said, which should reduce the risk of complications.
Cardiac rhythm management devices have faced declining sales in recent years, and the larger U.S. players-including Medtronic ($MDT), Boston Scientific ($BSX) and St. Jude Medical ($STJ) have been fighting aggressively to protect their share and grow new business despite ongoing market struggles.
Biotronik has a much smaller presence in the space in the U.S. than the other three, however, which makes its new product approval all the more interesting. The company has focused steadily on gaining FDA approvals for its cardiac products, such as its Lumax 740 DX, a first-in-class single-lead ICD to treat atrial fibrillation that won the FDA's blessing in February. And it is trying to carve out its own niche.
As it is, however, Biotronik's much larger competitors are fighting hard. Medtronic and Boston Scientific waged a tit-for-tat advertising war this week in the wake of Medtronic's new FDA approval for its Viva CRT-D implant. For now, however, Biotronik seems to be focusing more on emphasizing engineering prowess first.
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