Medtronic Makes Big Strides on Tiny Cardiovascular DevicesMedtronic Makes Big Strides on Tiny Cardiovascular Devices

Medtronic appears to be making significant progress when it comes to use of miniaturized cardiovascular devices, with news this week of the first U.S. implant of its Micra leadless pacemaker and global launch of its tiny Reveal LINQ Insertable Cardiac Monitor System.The Micra Transcatheter Pacing System has been successfully implanted at NYU Langone Medical Center in New York City, Medtronic said Thursday. Larry Chinitz, MD, conducted the procedure.A day before, Medtronic announced FDA 510(k) clearance and CE Mark for Reveal, accompanied by a worldwide launch.The Micra is the size of a horse pill¬-- one-tenth the size of a conventional pacemaker. The Reveal is one-third the size of a AAA battery, making it more than 80 percent smaller than other ICMs.

Both represents years of research work at Medtronic. And the Fridley, MN-based medical device giant isn't alone in this trend. St. Jude Medical, for example, spent $123.5 million last year to acquire Nanostim, a Milpitas, CA-based company that has a AAA battery-sized leadless pacemaker device that won European Union approval, and Boston Scientific has also been seeking to commercialize tiny pacemakers.Experts suspect the miniaturization breakthroughs are happening at this time because all of the computer industry's advances with microprocessing chips. Mobile device technology are increasingly spilling over into the medical device field. Tiny devices are simply less invasive for the body, and should hopefully reduce complications and chances of medical device failure. Both the Medtronic and Nanostim miniature pacemaker devices forgo running leads to the heart, avoiding problems such as infection. The devices both have long battery life--10 years for the Micra and 13 years for Nanostim."Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency," says Pat Mackin, president of Medtronic's Cardiac Rhythm Disease Management business and a senior vice president at the company.Medtronic's Reveal is placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest. It provides continuous and wireless monitoring capabilities. Through the Carelink Network, physicians can request notifications to alert them if their patients have had cardiac events."The simplified procedure and insertion tools make the device faster and easier for physicians to implant, which may expand access to more patients needing long-term monitoring," says Rod Passman, MD, professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in ChicagoWith the Micra, Medtronic is in the midst of a global clinical trial that will enroll up to 780 patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three months, are expected during the second half of the year.