The company, based in Fridley, Minnesota, confirmed to MedCity News that it’s building a lead-less pacemaker but offered no further details on the device, which reportedly can be implanted directly into the right ventricle.
Several medical device firms have been pursuing lead-less cardiac devices in recent years.
Nanostim Inc. in San Clemente, California is also working on a wireless pacemaker system that protects the heart in case the device pops loose.
EBR Systems Inc., based in Sunnyvale, California, is developing a system that uses ultrasound waves to activate a tiny device in the heart that converts the acoustic energy into electricity. Split Rock Partners, an early stage venture capital firm based in Eden Prairie, Minnesota, is a major investor in EBR Systems. The startup was co-founded by Richard Riley, a former director of engineering at Medtronic.
In May, Cameron Health Inc., based in San Clemente, announced promising results from a clinical study testing the first of its kind implantable cardioverter defibrillator (ICD) subcutaneous system that avoids the traditional method of snaking leads through veins. Boston Scientific Inc. (NYSE:BSX) is a investor in Cameron.
That Medtronic, the world’s largest medical device maker, should embrace lead-less devices represents a remarkable shift not only for the company but for the industry. For years, medical device makers raced to develop smaller and thinner leads, which allowed surgeons to implant devices with greater ease and flexibility.
Medtronic spent several years and millions of dollars to develop its next generation Sprint Fidelis leads. Yet in 2007, the company stopped selling the lead after reports that the wire broke apart inside the body. Many lawsuits from investors and patients followed, culminating in a major Supreme Court decision that ruled Medtronic could not be held liable for a device that met the FDA’s toughest regulatory standards.
Earlier this year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. About 260,000 Sprint Fidelis leads have been implanted in patients in the United States, with 143,000 still active. Leads can’t be easily removed, which is why Medtronic has advised patients to leave them in.
A report by UBS Investment Research said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent in four years. Medtronic’s own data suggests a 3 percent failure rate at three years.
“Fidelis may cast a long shadow” over the $5 billion ICD market, the report said.
Wireless devices could go a long way to ease the worries of nervous patients. Plus, implanting the devices without using wires would lower the cost of the surgery, industry analysts say.
It’s probably no accident that Medtronic is starting with the pacemaker — an ICD is a significantly more complicated device. But implanting the pacemaker directly into the heart presents its own safety problems if the device breaks loose.
“The potential of detachment of the lead-less biostimulator from the implant site would represent an immediately serious event, as for example, a pacemaker lost from the right ventricle can exit the heart via the pulmonic valve and lodge in the lung,” according to documents Nanostim filed with the U.S. Patent and Trademark Office.
Nanostim is working on a system that would feature “secondary fixation” — a tether made from biomaterials that would further secure the device to the heart and “prevent escape of the pacemaker into the circulation downstream from the heart.”