Cameron Health's under-skin ICD safe, effective

Cameron Health Inc, which agreed in March to be acquired by Boston Scientific Corp, said on Thursday its implantable heart defibrillator proved safe and effective for treating patients at risk for sudden cardiac arrest in a 330-patient clinical trial.

Cameron's implantable cardioverter defibrillator (ICD) is the first such device that does not use intravenous leads, or electric wires, to transmit electricity from the device to the heart. Leads are often the weak link of the defibrillator system and can cause serious complications.

"Conventional ICDs are a proven therapy with a long clinical track record; however, complications related to transvenous leads, or wires placed in the heart, can be quite serious for patients," said Dr Martin Burke, professor of medicine and director of the Heart Rhythm Center at the University of Chicago.

"We did not observe the typical lead-related complications with the S-ICD System, so having an alternative treatment for patients that can virtually eliminate transvenous lead complications is an important step forward for ICD therapy," he said.

Results of the study were presented at the Heart Rhythm Society's Annual Scientific Sessions in Boston.

Wells Fargo analyst Larry Biegelsen said the Cameron device will likely be a niche product, with initial usage likely to be limited to patients with failed traditional transvenous systems, patients at increased risk of infection, and those with vascular complications.

Implantable cardioverter-defibrillators (ICDs) Risks The procedure to implant an ICD has some risks, but they are rare. Risks of the procedure to implant an ICD include:

- Infection at the site where your ICD was implanted
- Allergic reaction to the medications used during the procedure to implant your ICD
- Swelling, bleeding or bruising where your ICD was implanted
- Damage to the vein where your ICD leads are placed
- Bleeding around your heart, which can be life-threatening
- Blood leaking through the heart valve where the ICD lead is placed

Boston Scientific has said the Cameron device represents a $1 billion market opportunity. Biegelsen said this equates to about 15 percent of the global ICD market.

(Reporting By Debra Sherman. Editing by Bernadette Baum and John Wallace)

Implantable Cardioverter Defibrillator Surgical Complications

While implantable cardioverter defibrillators (ICDs) are extremely effective and generally quite safe, it is possible for you to experience complications with your ICD system. These ICD complications fall into two types: surgical complications, and post-surgical complications.