Weighing the Benefits of Medtronic's Leadless Pacemaker

Posted by Shana Leonard on November 2, 2010

 

Medtronic recently unveiled its leadless pacemaker, which is still in development.

Medtronic unveiled its eagerly anticipated leadless pacemaker at the TEDMED conference last week and already has Cyberspace atwitter. The leadless pacemaker's debut comes just weeks after the news that Medtronic will pay $268 million to settle U.S. lawsuits related to its Sprint Fidelis defibrillator leads, which were implicated in 13 deaths and recalled in 2007 owing to their potential for fracture.

Smaller than a penny, the wireless pacemaker can be implanted in the heart using a catheter-based system, where it then attaches itself to the surrounding tissue. Using a nearby smartphone, physicians can wirelessly monitor and control the implant, reports Engadget.

“We would expect to begin human implants in the next three to five years. While we cannot predict the future of the market, we do believe that a leadless pacemaker could achieve market acceptance," Medtronic spokesperson Christopher Garland told me last month for an editorial I wrote on the potential impact of leadless CRM designs. The device, according to Medtronic, is part of its continuing focus on chronic disease management and miniaturization technology.

Aside from generating early buzz, however, the company is keeping relatively mum on the subject and issuing the caveat that the leadless pacemaker is still 'investigational' and in the developmental stages. The prospect of Medtronic's leadless pacemaker is exciting, though. There's no doubt that, if effective, eliminating troublesome transvenous leads from the equation could improve patient safety and care. And, depending on its success, the leadless pacemaker could create a completely new design model for pacemakers, thereby significantly changing the industry.

But could eliminating leads from CRM devices introduce new problems?

Several readers over at Engadget thought so. They immediately took to the comments section to post their concerns about the proposed use of smartphones to control and communicate with the device. "Am I the only one that thinks controlling something like this via a smartphone, while convenient, sounds like a recipe for disaster?" asked a poster with the screen name of freename. Added the poster Jwoofter, "Technology that helps us survive and live fulfilled lives like pacemakers are awesome, but the fact that you can control it with a smartphone is disturbing to me. Don't get me wrong, I love smartphones and I'm all for adding and creating new technology to make them cooler and better, but this is one place that, IMOP, smartphones should be left out of."

The use of smartphones is not a new conversation to those in the industry. But it's interesting to see the public's reaction. And they're not wrong; there are still many issues that need to be ironed out before we become dependant on smartphones for critical functions.

In a recent roundtable that I conducted for our upcoming 25th anniversary issue, Jim Ohneck of Valtronic Technologies (Solon, OH) addressed this topic of smartphones in healthcare. "Liability is a very big issue: What happens if a dropped call resulted in the death of a patient? Cell phone companies have huge dollars at risk, and they certainly will not want to be held accountable... I think there’s going to have to be some sorting out in the industry. A lot of people want to do this."

This might not be the case with the leadless pacemaker, as it sounds like doctors will use the phone nearby and not remotely, but it's definitely something to think about. What do you think about the leadless pacemaker? Could it be the way of the future? And what do you think about its use of smartphone technology to communicate? Let me know in the comments section. --Shana Leonard

Comments

To have a pacemaker which can be implanted without attaching leads to the heart is an ideal arrangement. In theory, you need very little power to stimulate the heart - assuming you can position the stimulus at a sensitive spot, and keep it there. It will be tough to work out, but perhaps still do-able, given time, funding, & intelligent development.

Using commercial cell-phones to Monitor & Program it is another part altogether. Besides the reliability of the cell-phones themselves (for these applications it may be possible to have "Extra-Reliable Units" made with the special Communications attachment. In this case it would not matter what the Networks are dropping - the Monitoring & Programming is "Local".

It is worth looking into - IF allowance is made to develop all the pieces properly.

Aside from the Smartphone issue, the pacemaker as indicated will fill a very small niche in the market. It can only stimulate one chamber, not two or three, where better control of hemodynamics is needed nowadays, especially in heart failure. It is also not rate-responsive, so it cannot modulate heart rate on its own. Hence, it is a VVI pacemaker, simply a 1960's device nicely repackaged half a century later. I also fear what would happen if the thing dislodges and enters the lungs. With such a small package, I wonder about the longevity of the internal battery. I would hate to see a person pass out at the wheel of his or her car because that person forgot to recharge the pacemaker one night.