Boston Scientific on a Roll With Transatlantic S-ICD Approvals

Marlborough, Mass.-based Boston Scientific Corp. has received U.S. Food and Drug Administration (FDA) and CE mark approval of the Emblem subcutaneous implantable defibrillator (S-ICD) system. The device is a treatment option that provides protection for patients at risk of sudden cardiac arrest (SCA), yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs). A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015.

“We are excited to offer the second generation S-ICD System to physicians as a compelling treatment option for the majority of ICD-indicated patients,” said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. “With the already established robust safety and efficacy clinical data, the Emblem S-ICD System is designed to enhance patient comfort, while still providing a less invasive treatment for patients at risk of cardiac arrest.”

The S-ICD system is implanted just under the skin and provides the patient the same protection as conventional units from cardiac arrest without invading the heart and blood vessels, the company claims. Leads in the heart may be associated with infrequent but serious complications, including lead displacement, fracture and systemic blood infections, or the need for lead extraction, which may lead to hospital readmission, increased mortality and associated costs.

The new generation Emblem S-ICD system is 19 percent thinner and is projected to last 40 percent longer than the previous S-ICD system. These improvements will further improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. Emblem is also enabled for remote patient management through the Latitude NXT patient management system for increased patient convenience.

“We are further strengthening our range of therapeutic solutions to protect patients from sudden cardiac arrest,” said Joe Fitzgerald, executive vice president and president of Rhythm Management at the company. “Boston Scientific is the first and only company to offer a fully subcutaneous ICD, and we expect to maintain leadership in this category through continued investment in technology and clinical science. We are very pleased with this earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the Emblem device in the United States.

The company also recently received long-awaited FDA approval for its Watchman catheter-delivered heart implant to help prevent blood clot migration.