Medtronic Inc. is moving forward with the U.S. launch of its next-generation Advisa DR MRI SureScan pacemaker system, following recent U.S. Food and Drug Administration approval.
The device is the first one to combine the most advanced pacing technology with proven Magnetic Resonance Imaging (MRI) access.
“It’s a full-feature device that allows the physician so much flexibility to tailor the programming. It is basically like smartphone inside the patient that helps the physician deliver the right kind of care needed individually by each patient,” said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, who was the lead investigator in the Advisa MRI clinical trial.
MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scans, and is critical for early detection, diagnosis and treatment, but the procedures are a risk for patients with traditional pacemakers because misinterpreted MRI-generated electrical noise can withhold pacing therapy or deliver unnecessary pacing therapy.
An estimated 200,000 patients in the U.S. annually have to forego an MRI scan because they have a pacemaker. Approximately 60 million MRI procedures are performed worldwide each year, and in 2007 there were approximately 30 million MRI scans performed in the U.S.
The new SureScan sets the device into an appropriate mode for the MRI environment.
“Now we are giving the best of both worlds,” said Brian Urke, general manager of the bradycardia division at Medtronic, the Minneapolis-based company whose Spinal and Biologics Business is based in Memphis. “We took the best pacing features from our non-MR conditioned pacing devices and added the MR-conditional features, with no trade-off for our customers and patients.”
The new model improves on Medtronic’s first-generation MRI-friendly pacemaker – the Revo – in many substantial ways.
“In a busy world, nobody wants to sit around in a doctor’s office,” Gimbel said. “The Advisa allows the physician to quickly check and verify the device is functioning appropriately, and get the patient on his/her way so they can do more productive things.”
Anti-tachycardia pacing, a new feature in the second-generation unit, can help terminate upper chamber racing heartbeats, according to Gimbel, and faster diagnostic capture management speeds the check-up process for clinicians and patients.
The new model also features an improved rate drop response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, as well as a higher upper tracking rate, making it more appropriate for younger and more active patients.
“We have several patients that like to bike, and they really like push their heart rates up to as high as 180 to 190 beats per minute,” Gimbel said.
The Advisa’s upper tracking rate is 210 beats per minute, compared to only 150 beats per minute in the Revo.
“One of the populations that these particular devices are most important for are younger people, and a reason why is that the alternative imaging scan is often time a CAT scan, which has ionizing radiation that has been associated with an increase in cancer risk,” Gimbel said.
Each year, approximately 320,000 people in the U.S. are implanted with a pacemaker, and it has been estimated that there is a 50 to 75 percent probability that cardiac device patients will be indicated for an MRI over the lifetime of their devices.
The implanted pacing system consists of the Advisa MRI device and two SureScan leads, which are insulated wires that carry precisely timed electrical impulses from the pacemaker in the patient’s chest to a specific point on the inner heart wall.
The Advisa clinical trials began in June 2010. Approximately 263 patients were implanted with a complete pacing system at 35 centers in the U.S., Canada, Australia, Europe and the Middle East. Advisa MRI received CE Mark approval in June 2009.
Medtronic is also using SureScan technology for other applications. The company just initiated the global launch in Europe for its new SureScan neurostimulation system, which is the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain designed for full-body MRI scans under specific conditions. The system is not yet approved for use in the U.S.
More than 100,000 Medtronic SureScan devices have been sold worldwide.