New Defibrillator Has No Wires Leading to the Heart – Clinical Trial in the US, Device has Europe CE Mark
Posted May 12 2010 10:54pm
Cameron Health in San Clemente, California has been developing the device. It is on the market in Europe, but not here in the US and a clinical trial is in place with 330 patients. Why is this big news? Here’s 3 recalls on defibrillators in the last 6 months.
The built in batteries of the devices have a lifetime of around 5 years, so at that point, when replacing a device, the decision is there to replace the cables at the same time. The physicians performing the removal process state that the learning curve is pretty large too, which brings up the next issue, finding a facility and physician who is qualified and knows how to do the removal procedure of the wires.
One patient had tissue so overgrown that the wire ended up in a vein. The Sprint Fidelis was formally recalled by Medtronic, as it sometimes failed to give the life saving jolt and on other occasions the opposite occurred with a number of jolts when not needed.
From the Website:
“Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and long term implantation of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure.
Cameron Health’s trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at 6 months for patients at risk of SCA.”
Researchers said Wednesday that they had developed a new type of implantable defibrillator that avoids the need to connect the device directly to the heart with wires, called leads, that are associated with complications of the traditional technique.
The researchers said a series of small studies showed the new defibrillator successfully detected and corrected potentially life-threatening irregular heartbeats after leads from the device were placed under the skin adjacent to the heart. Conventional devices employ leads threaded through veins into the heart itself.
The findings were presented at a meeting of the Heart Rhythm Society in Denver and published online by the New England Journal of Medicine. If the results are substantiated in a larger study, researchers said the device could become an attractive option for doctors and patients in what Wells Fargo Securities says is a $3.8 billion global market for the devices.