Boston Scientific gains FDA O.K. to tout longer defibrillator lifespans

Boston Scientific has launched its latest weapon in the extremely competitive defibrillator market: the guarantee of a longer lifespan for its products.

The Natick, MA medical device company ($BSX) has obtained FDA approval to revise labeling for 5 lines of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). It is meant to reflect new projections that some of the company's ICDs can last more than 10 years and that its CRT-D implants can last close to 8 years "nearly double that of comparable device models," according to Boston Scientific's big announcement.

The company's Incepta, Energen, Punctua, Cognis and Teligen ICDs and CRT-Ds are affected by the new labeling, which is based on updated use data the company submitted to the FDA. (Disclaimer: device lifespan can vary depending on the model type and settings.) To back that up, the devices now have 10-year warranties on its devices in the U.S. and a number of international markets, it says.

What led to the change? The company, in part, credits its "proprietary advanced battery technology," which was first added to the Cognis and Teligen devices in 2008 and is now in the company's newer models as well.

Once again, this reflects how competitive the ICD and CRT-D markets are now, as the major players try to boost declining ICD and cardiac rhythm management division sales. Earlier in May, Biotronik won an FDA regulatory sign-off for its new Lumax 740 ICD and CRT-D devices. And St. Jude Medical ($STJ) also just gained FDA approval for its new miniature Ellipse implantable ICD. Cameron Health is also waiting for FDA approval for its first-in-the-U.S., under-the-skin implantable defibrillator, while Boston Scientific has a $150 million bid for the company that remains pending. Medtronic ($MDT) remains a player in the space as well.

- read the release

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.