October 16, 2013
Miniature, Wireless Pacemaker Approved In Europe
Brett Smith for redOrbit.com - Your Universe Online
American start-up Nanostim announced earlier this week its miniaturized pacemaker has been granted approval for use by European Union officials. Cardiac pacemakers treat slow heart rates by monitoring the heart’s rhythm and providing an electrical stimulus when the beat becomes too slow.
Traditional models are installed by cutting a patient open and creating a cavity in the body to hold the pacemaker and its associated wires. These wires are the most likely part of a traditional pacemaker to fail and the space created for the pacemaker is also highly susceptible to infection.
The newly-approved Nanostim pacemaker avoids many of the problems associated with traditional pacemakers. First, it is placed directly into the heart using a catheter that is inserted through the femoral vein located near the groin. This method of delivery is less invasive and eliminates the scarring associated with conventional pacemaker surgeries.
The new device has also done away with the wires used in conventional models, cutting the risk of infection and malfunction. According to Nanostim, the wire-free, or 'leadless,' design also increases the patient's range of activity.
The company also said the procedure to fit the pacemaker only lasts around half an hour, and the device is easily retrievable so that the battery can be readily replaced.
“For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges,” said Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. “This revolutionary technology offers my patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets. This is the future of cardiac pacing.”
"This is a potentially exciting development but it's early days,” Pearson said. "Before this leadless pacemaker becomes widely available, we need a better understanding of how long it will last, as well as how easy it is to replace if necessary. As our knowledge of this new pacemaker widens, so too will the expertise needed to fit this potentially exciting device."
Nanostim, which has had several wire-based pacemakers recalled, was recently acquired by medical device maker St. Jude Medical.
“The Nanostim leadless pacemaker represents one of the most important advances in the history of pacing technology, and builds on St. Jude Medical’s strong history of pacing innovation – beginning with the first implantable pacemaker in 1958 through the introduction of quadripolar cardiac resynchronization therapy pacing,” said Dr. Eric S. Fain , president of the company’s Implantable Electronic Systems Division.
“We look forward to welcoming Nanostim employees to St. Jude Medical and to continuing our legacy of transforming the treatment of cardiac rhythm disorders with pioneering technology.”
“Nanostim’s focus on bringing innovative technologies to the market closely aligns with St. Jude Medical’s commitment to developing leading products and treatment options for patients and physicians worldwide,” added Nanostim CEO Drew Hoffman. “We are pleased to have recently received CE Mark approval for the Nanostim leadless pacemaker. Nanostim looks forward to now working as part of St. Jude Medical to further advance our commercialization initiatives and expand this technology into new and existing markets.”