FDA APPROVES WORLD’S SMALLEST PACEMAKER IN US

The Medtronic Micra® TPS is the First Transcatheter Pacemaker Approved in the U.S.

Gives Patients Access to the Most Advanced Pacing Technology at One-Tenth the Size of Traditional Devices

DUBLIN – April 6, 2016 – Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of the world’s smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart —providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

“For many years we’ve been hopeful that a transcatheter pacing solution – with a safety and effectiveness profile on par with conventional devices – would become available, and today Micra has achieved this milestone,” said Dwight Reynolds, M.D., regent’s professor and chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center, and principal investigator in the Micra TPS Global Clinical Trial. “In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins. This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology.”

Comparable in size to a large vitamin, the Micra TPS is attached to the heart with 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 related to such leads and pocket are eliminated—as are any visible signs of the device. The device responds to patients’ activity levels by automatically adjusting therapy...

The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction...

“Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure division. “We are thrilled to be the first to introduce a transcatheter pacemaker to patients in the U.S., and we’re looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients.”

The Micra TPS was awarded CE Mark in April 2015 based on early data from the Medtronic Micra TPS Global Clinical Trial. It is intended for use in patients who need a single-chamber pacemaker. The device was designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink® Network; remote monitoring of Micra devices is expected to be available later this year.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

Multimedia Info - photos and videos
A multimedia version of this release with a patient story, animation and downloadable graphics can be found at: http://bit.ly/1SwDGpX


 

4 Comments

thank you

by hopefulheart - 2016-04-11 01:04:00

Amazing reading.....hopefully, all heart patients have a lot more freedom and safety to look forward to in the future. There will be some interesting discussions ahead on site....what lies ahead for those of us already implanted with dinosaur devices and leads, costs, qualified medical personnel, etc.. I will leave when it is time knowing now my grandson with a congenital heart issue has a chance for an easier life when he needs technological assistance. Celebrate for hearts all over the world as technology moves forward! ! !
hopefulheart

Cool

by Good Dog - 2016-04-11 11:04:53

When I was at the Cleveland Clinic last October a Doc handed me that new PM and said have a look at this. He said it was a demo that they received from Medtronic. It is less than half the size of a AAA battery. Pretty cool!

Only problem is that it is designed only for single chamber use. As small as it is, it still seems a little too large to be able to pass through the tricuspid valve (but I don't know that for sure). So although my hope is that it is a stepping stone to a lead-less dual chamber PM, it doesn't seem likely anytime soon.

For the younger PM patients especially, it really would be nice not to have to worry about the potential complications from leads.

David

Dual chamber version being developed

by SaraTB - 2016-04-12 08:04:30

Good Dog: my EP showed me one of those demo models as well, while pointing out that although it was only single chamber right now, and therefore no use for me, they were working on developing a dual chamber model (don't ask me how) and it would come in time. Alas, not in time for my next replacement, but maybe the one after that?

I know we have two members here who are part of the trial but I don't think we've seen an update recently. My recollection was that they were both doing very well.

Love my Micra!

by tammyjk1021 - 2016-05-26 08:05:07

I was part of the trial. I have my good days and my bad days but I don't think that has to do with my PM. I have to admit that being part of the trial added some stress and that probably had more to do with my increased PVC's. I don't think I would have made a different decision though.

The one thing that I nor anyone else close to me thought about was the fact that without scars ect. no one knows I have a PM. I got the bracelet but that bothered me too much. I spoke with a nurse that tried to shock a patient that she didnt realize had a pacemaker, she told me it threw her across the room. I decided then to get a small tattoo on my left wrist to let them all know.

The only other weird thing was an x-ray tech that no one told about my PM. She came running out checking me for a bullet hole LOL. It looks very much like a bullet on an x-ray I guess. Had a couple of x-ray techs pretty astounded since then because it's so small.

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The experience of having a couple of lengths of wire fed into your heart muscle and an electronic 'box' tucked under the skin is not an insignificant event, but you will survive.