Medtronic plc (NYSE: MDT) that has developed the Micra Transcatheter Pacing System (TPS), the world’s smallest pacemaker, will hit markets in June but the price is almost double the traditional pacemakers, at around Rs.2.5 lakh and taxes added extra.
Measuring less than one-tenth the size of traditional pacemakers, the Micra TPS device provides advanced pacing technology while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart. It is useful for people whose hearts are beating too slowly or irregularly as it stimulates the heart muscle with precisely-timed discharges of electricity that cause the heart to beat in a manner similar to the natural heart rhythm.
Comparable in size to a large vitamin, the Micra TPS does not require the use of wires, known as “leads,” to deliver pacing therapy; rather, it is attached to the heart via small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
“Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical ‘pocket’ under the skin, so potential sources of complications are eliminated – as are any visible signs of the device,” said Philippe Ritter, cardiologist at Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire (CHU) Bordeaux. “While the Micra TPS is dramatically smaller, it is a fully self-contained pacemaker that still delivers the most advanced pacing technology available to patients.”
Once positioned, the Micra TPS is attached to the heart wall and can be repositioned or retrieved, if needed. The device responds to patients’ activity levels by automatically adjusting therapy. Despite its miniaturized size, the Micra TPS has an estimated 10-year battery life and is approved for full body MRI scans, providing patients with access to the most advanced imaging diagnostic procedures.
The device was awarded CE Mark based on results from the first 60 patients in the Medtronic Micra TPS Global Clinical Trial.
“Our cross-functional teams have been working for years to redefine engineering limits and production capabilities by radically reducing the size of medical devices by more than 90 percent while continuing to innovate upon the existing technology,” said Brian Urke, vice president and general manager of the Cardiac Rhythm and Heart Failure’s Brady business, which is part of Medtronic.
Pacemakers help restore the heart’s rhythm by sending electrical signals to the heart to increase the heart rate, which can relieve the symptoms of bradycardia. Pacemaker therapy is the most common way to treat bradycardia (a slow heartbeat), with more than one million pacemakers implanted worldwide each year. The Micra device is available for patients who benefit from single-chamber pacing as it paces one chamber of the heart, the right ventricle.
Medtronic plc., headquartered in Dublin, Ireland, is planning to release the device in June this year. Being a wireless or without ‘leads’ as in existing devices they often turn cumbersome since they can’t be taken out with the pacemaker and forms a clump near the heart. But with TPS, successive implants will become easier.
While existing pacemakers cost up to Rs 1.5 lakh, the TPS could be priced at Rs 2.5 lakh and it remains to be seen whether health insurance covers these devices or not.