Biotronik

Biotronik receives FDA device approval for ‘smaller, thinner’ one-lead implantable cardiac defibrillator

Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device. This “smaller, thinner” new generation platform allows for a […]

Analyst: Biotronik gains ground on the Big Three in medical devices

In the automotive market, it was Japan that gave the Big Three a run for their money. In medical devices, the Big Three — Fridley, Minnesota-based Medtronic (NYSE:MDT); Natick, Massachusetts-based Boston Scientific (NYSE: BSX); and Little Canada, Minnesota-based St. Jude Medical (NYSE:STJ) — better watch out for Biotronik, a German medical devices firm. Especially in […]

GPO Novation continues its Medtronic rebound phase, signs Biotronik

Novation may have been jilted by Medtronic (NYSE:MDT) in February, but the group purchasing organization hasn’t let any grass grow under its feet in its search for new partners. The Irving, Texas-based GPO said it signed a two-and-a-half-year deal with German cardiac rhythm device maker Biotronik, hard on the heels of inking another 30-month pact […]

Biotronik outlines ‘exploding’ defibrillator response

Friday evening, I met with Rex Richmond (Vice President of Marketing) and Dan Schlewitz (Executive Vice President U.S.A. Sales) from Biotronik, Inc. to hear their side of the controversy surrounding the withdrawal of a case report previously published in Europace pertaining to an "exploding" Biotronik implantable cardiac defibrillator (ICD). They claimed they have been transparent regarding the reporting of this incident to the FDA, filing their incident report with the FDA within seven days of the event (within thirty days is required). Mr. Richmond granted me permission to release their internal company memo (pdf) circulated to their employees regarding the case report.