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.
The main risks related to ICD implantation surgery include:
- bleeding
- infection
- collapsed lung
- damage to the heart or to a blood vessel
The overall risk of having any of these complications is around 2 to 3%. The risk of actually dying from an ICD implantation procedure is very low - in most people, well under 1%.
Most of the surgery-related complications end up being relatively minor and relatively easily treated. The major exception to this general “rule” is infection. If the ICD becomes infected, then the entire ICD system (the ICD generator and all the leads) usually must be removed in order to successfully cure the infection with antibiotics - and once the infection is cleared up, another ICD system will need to be implanted.
You will be exposed to these same surgical risks each time your ICD generator needs to be replaced (roughly every 6 to 7 years, when the battery begins to wear out). Your risk from this replacement surgery is generally lower than for the initial surgery. This is because the replacement surgery usually requires only replacement of the ICD generator itself, and not the ICD leads, which reduces to nearly zero the risk of collapsed lung, and of damage to the heart or blood vessels. However, there is some evidence that the risk of infection is higher with replacement surgery than with the initial surgery.
###
(Reuters)