Nov. 19 - The world's first leadless pacemaker has been approved for sale in the European Union (EU). According to its U.S. creator Nanostim, acquired recently by St. Jude Medical, the device is much less invasive than a conventional pacemaker, and will make life easier for many heart patients. Jim Drury reports.
St Jude Medical's cardiac pacemaker works without a lead, the first of its kind to be approved for use. Conventional pacemakers require long wires fitted inside the body and connected to a battery pack, to stimulate the heart muscle electrically, and keep it beating at a normal rate. Surgery is invasive and British cardiologist David Begley says the leads can fracture or move around, requiring their removal. SOUNDBITE (English) DAVID BEGLEY, CONSULTANT CARDIOLOGIST AT PAPWORTH HOSPITAL, SAYING: "The lead goes under an enormous amount of stress throughout the lifetime of the device and it's probably the likeliest component to fail of the device." Leads can also cause potentially deadly infections like endocarditis. But the leadless device, created by California start-up Nanostim overcomes that problem. The device contains its own battery and is inserted non-invasively, via steerable catheter, says St Jude chief medical officer Mark Carlson. SOUNDBITE (English) MARK CARLSON, CHIEF MEDICAL OFFICER AT ST. JUDE MEDICAL, ON THE LEADLESS PACEMAKER, SAYING: "This device is implanted through the femoral vein, a vein in the groin, much like a heart catheterisation procedure. It is a straight shot up to the heart where this device can be attached directly inside the heart to provide the impulse to drive the heart beat." Carlson says the procedure takes just 30 minutes, minimising the risk of complications associated with standard pacemakers. SOUNDBITE (English) MARK CARLSON, CHIEF MEDICAL OFFICER FOR ST. JUDE MEDICAL, ON THE LEADLESS PACEMAKER, SAYING: "No incision in the shoulder, no can under the skin, no wire to the heart that might dislodge during the first few hours or days after the implant. The patient can go about their normal activities that otherwise would be restricted in the first 30 days after implant." But David Begley says, that while a big step forward, the new leadless device won't help all his patients at Papworth Hospital. SOUNDBITE (English) DAVID BEGLEY, CONSULTANT CARDIOLOGIST AT PAPWORTH HOSPITAL, SAYING: "This potentially could be a way forward for patients who only require one lead. Currently that accounts for about a third of patients that we implant a pacemaker in, but the heart is a complex arrangement of chambers and those chambers need to communicate with each other, so if that communication needs to be maintained then this device is not suitable." The device has just been approved for use across Europe. Further trials are required before it gets US approval.