Boston Scientific Receives FDA Approval Of First-In-Class S-ICD® System For Patients At Risk Of Sudden Cardiac Arrest

Date: Oct-07-2012The U.S. Food and Drug Administration has granted Boston Scientific Corporation (NYSE:
BSX) regulatory approval for its S-ICD(R) System, the world's first and only commercially
available subcutaneous implantable defibrillator (S-ICD) 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 thin, insulated wires -- known as electrodes or 'leads' -- to be
placed into the heart. This leaves the heart and blood vessels untouched, offering
patients an alternative to transvenous implantable cardioverter defibrillators (ICDs),
which require leads to be placed in the heart itself.

"The S-ICD System establishes the first new category of cardiac rhythm management
devices since the introduction of cardiac resynchronization therapy," said Raul Weiss,
M.D., Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University.
"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 S-ICD System met the primary endpoints of
the study, and results were presented earlier this year at the Heart Rhythm Society 33rd
Annual Scientific Sessions. The study results support that the S-ICD System is an
important new treatment option for a wide range of primary and secondary prevention
patients.

"With the addition of the S-ICD System, we believe Boston Scientific has a compelling
and highly differentiated portfolio that will help fuel our growth strategy," said Hank
Kucheman, chief executive officer, Boston Scientific. "We are the only company to offer an
FDA-approved subcutaneous implantable defibrillator and expect this to be the case for
several years. The S-ICD System, coupled with our numerous recent regulatory approvals and
our other innovative products, such as the WATCHMAN(R) Left Atrial Appendage Closure
Device and Alair(R) Bronchial Thermoplasty System for the treatment of severe asthma,
demonstrates our continued commitment to developing and bringing to market innovative
products for physicians and their patients."

Sudden cardiac arrest 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. Recent estimates show that approximately 850,000 people in the
United States are at risk of SCA and indicated for an ICD device, but remain unprotected.

"Each year, thousands of patients indicated for an ICD are not referred to a
specialist and remain untreated," said William T. Abraham, MD, FACC, Director, 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."

The S-ICD System is designed to provide the same protection from sudden cardiac arrest
as transvenous ICDs. The system has two main components: (1) the pulse generator, which
powers the system, monitors heart activity, and delivers a shock if needed, and (2) 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. Implantation with the S-ICD System is straightforward
using anatomical landmarks, without the need for fluoroscopy (an x-ray procedure that
makes it possible to see internal organs in motion). Fluoroscopy is required for
implanting the leads attached to transvenous ICD systems.

Boston Scientific expects to begin a phased 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 company acquired the S-ICD System earlier this year when it completed the
acquisition of Cameron Health, Inc. The S-ICD System received CE Mark in 2009 and is
commercially available in many countries in Europe as well as in New Zealand. To date,
more than 1,400 devices have been implanted in patients around the world. To download a
high-resolution image of the S-ICD System go to:
http://bostonscientific.mediaroom.com/home.

The S-ICD System is intended to provide defibrillation therapy for the treatment of
life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic
bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring
ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The WATCHMAN device is an investigational device in the United States. It is limited
by applicable law to investigational use and not available for sale.

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.