Medical Device Daily Senior Staff Writer

Lead failures have plagued the implantable cardioverter defibrillator (ICD) market for years, so it is only natural that ICD makers would develop a way to give patients all the benefits of having an ICD without the risks associated with having wires running from the device into the heart itself. The FDA has granted Boston Scientific (Natick, Massachusetts) approval for its S-ICD system, which the company says is the world's only commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden cardiac arrest (SCA).

The S-ICD system sits entirely just below the skin without the need for electrodes or leads to be placed into the heart. This leaves the heart and blood vessels untouched, the company noted, offering patients an alternative to transvenous ICDs.

Hank Kucheman, CEO of Boston Scientific, told Medical Device Daily that the system creates a significant market opportunity for the company and its shareholders, as well as an important option for patients who either are not good candidates for transvenous ICDs or are eligible but don't want the traditional devices because of the risks.

The company acquired the S-ICD system earlier this year when it completed the acquisition of Cameron Health (Medical Device Daily, June 11, 2012). Boston Scientific paid $150 million at closing but the agreement called for an additional potential payment of $150 million to be made upon FDA approval of the S-ICD system and up to an additional $1.05 billion of potential payments to be made upon the achievement of specified revenue-based criteria over a six-year period following FDA approval.

Kucheman says the addition of the S-ICD system gives Boston Scientific a "compelling and highly differentiated" portfolio that will help fuel the company's growth strategy. "We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years."

SCA is an abrupt loss of heart function. Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation, Boston Scientific noted. The company says recent estimates show roughly 850,000 people in the U.S. are at risk of SCA and indicated for an ICD device, but remain unprotected.

"This is just one piece, but a very important piece, of the puzzle," Kucheman said. "Obviously we're very excited by the introduction of this technology, we look forward to getting it into the market place in the very near future and helping the patients here today have another option."

Ken Stein, MD, chief medical officer of the cardiac rhythm management group at Boston Scientific, told MDD that "as far as I'm concerned, this is the biggest innovation" in the cardiac space in over a decade. For patients who are not indicated for an ICD because they cannot have leads in their heart, the S-ICD offers a "lifesaving option that they never had access too" before. It also offers an alternative option for patients who remain unprotected even though they are eligible for an ICD device.

"We know there are a lot of patients indicated for defibrillators today who don't get them because they are concerned about the risks involved with having leads placed into the heart," Stein said. "This gives them a less invasive option and it avoids a lot of the disadvantages of having leads in the heart."

The S-ICD system is designed to provide the same protection from SCA as transvenous ICDs. The system has two main components: the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and the electrode, which enables the device to sense the cardiac rhythm and deliver shocks when necessary. Both components are implanted just under the skin — the generator at the side of the chest, and the electrode beside the breastbone. Unlike transvenous ICDs, the heart and blood vessels remain untouched.

"This still has an electrode," Stein explained. "But instead of having to put the electrode through leads that go into the heart" the electrode is implanted just under the skin. The device is designed to sense the heart's rhythm and provide protection from SCA when needed.

The company also noted that implantation of the S-ICD system is straightforward using anatomical landmarks, without the need for fluoroscopy, which is required for implanting the leads attached to transvenous ICD systems.

Boston Scientific says it expects to begin a phased U.S. launch of the S-ICD system that will expand over time as medical professionals are trained on the safe and effective use of the system. The S-ICD system received CE mark in 2009 and is commercially available in many countries in Europe as well as in New Zealand.

"The S-ICD system establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy," said Raul Weiss, MD, associate professor-clinical, cardiovascular medicine at The Ohio State University (Columbus). "Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart."

Approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients at risk of SCA. The device met the primary endpoints of the study, and results were presented earlier this year at the Heart Rhythm Society (Washington) 33rd annual scientific sessions.

"Each year, thousands of patients indicated for an ICD are not referred to a specialist and remain untreated," said William Abraham, MD, director of the Division of Cardiovascular Medicine at The Ohio State University Heart Center. "The S-ICD system is an important new treatment option that has the potential to improve patient acceptance of ICD therapy."

Amanda Pedersen, 912-660-2282;

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