Cameron Health’s Leadless Implatable Cardiac Defibrillator Looking to Get FDA Approval

Cameron Health’s Leadless Implatable Cardiac Defibrillator Looking to Get FDA Approval

Cameron Health’s S-ICD® System Scheduled for FDA Panel Review on April 26, 2012

World’s Only Completely Subcutaneous Implantable Defibrillator is an Important New Alternative for Patients at Risk of Sudden Cardiac Arrest

SAN CLEMENTE, Calif. (March 19, 2012) – Cameron Health, Inc. (“Cameron Health”) announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the Premarket Approval (PMA) application of the S-ICD® System on April 26, 2012.

“The FDA advisory committee meeting represents a significant step towards obtaining U.S. approval of the S-ICD System,” said Kevin Hykes, Cameron Health’s President and CEO. “We look forward to the opportunity to discuss the safety and efficacy of the S-ICD System with the FDA review team. Our clinical data will demonstrate that the S-ICD System is a valuable new treatment option for patients at risk of sudden cardiac arrest.”

The FDA advisory panel will review clinical data on the safety and efficacy of the S-ICD System including the results of a Pivotal IDE Clinical Study of 330 patients at risk of SCA. The PMA application was submitted to the FDA in December, 2011.

On March 8, 2012, Boston Scientific Corporation announced that it would exercise its option to acquire Cameron Health, Inc. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

About the S-ICD System

The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, removing the need for lead placement inside the heart. Essentially, the S-ICD System eliminates the major clinical complications associated with transvenous leads. The S-ICD System detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias that can lead to sudden cardiac arrest. When abnormal arrhythmias are detected, the S-ICD System delivers an 80 Joule shock to restore the heart’s normal rhythm. Left unaddressed, these disorganized heart rhythms are often fatal.

About Sudden Cardiac Arrest (SCA)

SCA is a sudden, abrupt loss of heart function. Most SCA 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 U.S. are at risk of SCA and indicated for an ICD device, but remain unprotected. In fact, less than 35 percent of patients who are indicated for an ICD receive one. SCA is not the same as a heart attack. A heart attack is a malfunction caused by blockage in a vessel that supplies blood to the heart, which may permanently damage part of the heart. Unlike SCA, most people survive a first heart attack. SCA is an “electrical” malfunction of the heart that results in no blood flow to the body or the brain. SCA is fatal if left untreated. ICDs are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.

Cameron Health Inc.’s novel defibrillator used to shock a stopped heart has been tied to inappropriate shocks and infection rates, U.S. regulators said.

A study of the San Clemente, California-based company’s device in 314 patients showed 48 episodes of shocks in 38 patients that were inappropriate and higher infection rates compared with devices with leads inserted through a vein, according to a report released today by Food and Drug Administration staff. Advisers to the agency are scheduled to meet April 26 to discuss the device’s safety and effectiveness.

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Boston Scientific Corp. (BSX) agreed in March to purchase closely held Cameron Health for as much as $1.35 billion for the device called the S-ICD System. Boston Scientific fell 1.4 percent to $5.86 at the close in New York. The FDA staff also questioned whether the Cameron Health data is sufficient to assure the device works.

“FDA has raised several questions regarding the totality of the safety and effectiveness data submitted,” agency staff wrote.

Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.

Ward Dykstra, a spokesman for the company, didn’t immediately return a phone call requesting comment on the staff report.

No Wires

Cameron Health’s defibrillator, approved in Europe, is implanted completely under the skin, eliminating the need for lead placement inside the heart, the company said. About 850,000 people in the U.S. are at risk for sudden cardiac arrest, which is rapid or chaotic heart activity that leads to loss of function, and are eligible to use an implantable defibrillator, according to the company.

In the study of the Cameron Health device, most of the shocks deemed inappropriate were from oversensing, according to the FDA staff report. Twenty inappropriate shocks represented normal device function and were consistent with what would occur with a defibrillator inserted in a vein.

Cameron Health (San Clemente, CA), which was purchased in March by Boston Scientific, is reporting that the FDA’s Circulatory System Devices Panel has recommended approval for its S-ICD system, an implantable defibrillator that unlike traditional ones does not use intracardiac leads. Instead, an electrode implanted vertically under the skin on the chest senses the heart’s electrical signals and corrects them with appropriate shocks.

Though the recommendation for approval points to a likely final clearance of the device by the US FDA, the latest study of the S-ICD system did show it generates more unnecessary shocks, leads to more infections, and loses battery life faster than traditional ICDs. According to Bloomberg wire’s Apr 23, 2012 article, “Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.”

Source : http://www.bloomberg.com/news/2012-04-23/cameron-health-s-defibrillator-raises-safety-concerns.html

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