Boston Scientific scores FDA approval for a new crop of implantable cardiac devices

Boston Scientific's Inogen X4 CRT-D--Courtesy of Boston Scientific

Boston Scientific ($BSX) won FDA approval for a new crop of implantable defibrillators and heart failure devices, helping the company move forward with sales and development of its cardiac rhythm management system.

The company's Dynagen Mini and Inogen Mini ICDs and the Dynagen X4 and Inogen X4 CRT-Ds treat patients who are at risk for sudden cardiac death or who suffer from heart failure by shocking racing heartbeats back into normal rhythm. Boston Scientific claims its Mini ICDs are 20% smaller by volume and 24% thinner than rival devices from other companies.

"The tiny size of the Mini ICD provides a real benefit to some patients, in particular those with a smaller frame," Dr. Hans-Joachim Trappe from University Marien Hospital Herne, Hospital of Ruhr-University, Bochum, Germany, said in a statement.

An FDA OK for its implantable cardiac devices could be exactly what Boston Scientific needs to jump-start sales and continue to engineer a turnaround. While the company posted promising Q4 2013 numbers, it saw declining revenue for its cardiac products. In the fourth quarter of 2013, the Massachusetts-based device giant posted a 6% drop in interventional cardiology sales compared to the same period in 2012. The company fared even worse in 2012, as cardiac rhythm management--its second largest business--declined 8.6% on the year due to pricing pressures and a difficult reimbursement economy.

Regulatory approval also helps Boston Scientific keep a leg up on its competition, as devicemakers like Medtronic ($MDT) and Biotronik are developing their own ICD products. Earlier this month, Medtronic won an FDA nod for a new fleet of pacemakers and defibrillators, and Biotronik proceeded with a study of its MRI-safe ICD device.

Meanwhile, the company is eyeing emerging markets as a potential avenue for growth. Boston Scientific recently launched its subcutaneous ICD system in Asia, the first step in its Eastern marketing effort.

"With these new devices and our current line of long-lasting ICDs and CRT-Ds, including the world's only subcutaneous ICD, we believe we offer the very best range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronization therapy," Joe Fitzgerald, president of the Rhythm Management division of Boston Scientific, said in a statement. "Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients."

- read the release
- here's Reuters' take

Special Report: Devicemakers plot paths out of CRM funk - Boston Scientific

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