Medtronic follows St. Jude Medical with leadless pacemaker U.S. trial milestone

Medtronic's Micra transcatheter pacing system--Courtesy of Medtronic

Medtronic ($MDT) said it has implanted its new supersmall leadless pacemaker in its first U.S. patient as part of a global clinical trial of the device. This comes a few weeks after rival St. Jude Medical ($STJ) hit the same milestone with its own competing product.

The Minnesota device giant said its Micra transcatheter pacing system has been successfully implanted into a patient at NYU Langone Medical Center. Medtronic bills it as the world's smallest--it's the size of a large vitamin and about one-tenth the size of a conventional pacemaker. Surgeons deliver the device through a catheter inserted into the femoral vein and it is then attached to the heart wall, though it can be repositioned or taken out if needed. An electrode at the end of the device delivers electrical impulses to the heart, and no wire leads are required.

As Medtronic explained, this U.S. milestone is part of its single-arm global trial expected to enroll 780 patients at 50 centers. Initial results are expected in the second half of 2014, when Medtronic discloses results from the first 60 patients after three months of follow-up.

For those that don't follow the pacemaker industry, it would be a major advance to bring a leadless pacemaker to market, as well as something small enough that could just be inserted through a catheter into the femoral vein. Pacemakers are generally well-performing devices, but patients tend to have complications--and devicemakers face manufacturing challenges--with the pacemaker leads. They also must be implanted under the skin in a surgical procedure.

Medtronic's big milestone aside, St. Jude Medical did it first earlier in February. St. Jude announced then that doctors implanted its Nanostim leadless pacemaker into a patient at the Mount Sinai Hospital in New York--a 77-year-old woman with atrial fibrillation--also as part of a pivotal FDA trial. The device already has a CE mark. Similarly, St. Jude bills Nanostim as being one-tenth the size of existing cardiac pacemakers.

- read the release

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