ICDs are used to deliver high-energy electrical shocks when the heart is beating in a rapid, uncontrolled fashion, restoring the heart back to a normal rhythm. Traditionally, ICDs are indicated for patients who survived a sudden abrupt loss of heart function or have a history of heart rhythm abnormalities. Recent studies (MADIT I & II) have demonstrated that ICDs can reduce mortality when used as a prophylactic therapy in patients who are predisposed to sudden cardiac death.
Cameron's product is a leadless ICD implanted in subcutaneous tissue. The device incorporates technology that both receives electrical impulses from the heart to diagnose rhythm abnormalities, and provides an electrical shock to restore normal cardiac rhythm, thus eliminating the need for leads to be implanted in the heart. Unlike current ICDs, the Cameron ICD is not surgically attached to the heart, thus simplifying the implant procedure and potentially reducing long-term complications related to leads.
Cameron has initiated clinical testing and has utilized this technology in approximately 90 patients outside the United States. The company is currently in discussions with the U.S. Food and Drug Administration about U.S. clinical trials, and it expects to begin an Investigational Device Exemption trial in 2005.
The ICD market is in excess of $2.0 billion annually worldwide and is expected to grow approximately 15 percent annually over the next five years.
"Next to the market for drug-eluting stents, the ICD market represents the largest opportunity in medical devices," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "The Cameron team is developing an innovative, less-invasive alternative for treating cardiac rhythm abnormalities. The next-generation Cameron technology may expand the number of cardiologists willing to implant ICDs, thus reaching a broader patient population. We would like to congratulate the Cameron team for creating this innovative new technology."
"Our technology is designed to provide cardiologists with an ICD that is easier to implant and program than existing implantable defibrillators," said Jay Warren, President of Cameron Health, Inc. "We have put together an outstanding technical team, and I am very pleased with the significant progress they have made toward starting our pivotal clinical study."
"A significant segment of the population at risk for sudden cardiac arrest do not currently receive ICD therapy," said Dr. Gust Bardy, a clinical professor of medicine at the University of Washington and co-inventor of the Cameron ICD. "Many physicians find today's ICDs overly complex and difficult to implant and program. Cameron