Nanostim's device received approval in Europe, but it has not yet been approved by the FDA. Enrollment in its investigational device exemption study is expected to begin in the first half of 2014, a St. Jude Medical spokeswoman said.
St. Jude Medical, one of the largest makers of cardiac rhythm management devices, in 2011 had to recall leads for its Riata and Riata ST pacemakers after reports of premature lead insulation failure. Most implantable heart defibrillators have leads, which can often lead to revision procedures. Experts say that lead extraction can have “unavoidable risks,” and hospitals have said this can lead to higher costs.
Boston Scientific last year had a subcutaneous implantable heart defibrillator approved by the FDA. That device does not require hardware to be implanted into the heart, which the company has said may lead to cost-savings.
Dr. Ken Stein, chief medical officer for Boston Scientific's cardiac rhythm management group, last year told Modern Healthcare: “By avoiding issues with lead failures, by avoiding some of the operative complications, which are things that can lead to very high healthcare expenditures, we are very confident that this is going to play very well in a cost-conscious environment.”
Biotronik, another manufacturer of cardiovascular medical devices, in February reported approval of an implantable cardioverter defibrillator that operates with one lead rather than two and has atrial sensing capabilities.
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