|Medtronic's Micra transcatheter pacing system--Courtesy of Medtronic|
Medtronic ($MDT) successfully implanted its tiny leadless cardiac pacemaker in its first patients as part of a global clinical trial, chalking up another victory for the device on its path toward regulatory approval.
Results from a single-arm, multicenter study showed that at one and three months, four patients outfitted with the company's Micra Transcatheter Pacing System (TPS) had no major complications postimplant. The study began in December 2013, and the four individuals who received the device were between the ages of 74 and 83. Medtronic plans to enroll 780 patients at approximately 50 centers worldwide to evaluate its cardiac pacemaker, and has already recruited 80 individuals to take part in the study, the company said in a statement.
"We are encouraged by these preliminary results and are hopeful that this less invasive procedure will provide similar outcomes for all patients in the Trial," said Dr. Clemens Steinwender, head of cardiology at the Linz General Hospital in Linz, Austria, who presented the data at Cardiostim 2014.
The Minneapolis-based device giant touts its Micra system as the world's smallest pacemaker, about one-tenth the size of a conventional pacemaker and roughly equivalent in size to a large vitamin. Unlike traditional pacemakers, the device does not require surgical incision or the use of wires, or "leads," to connect to the heart. Instead, physicians deliver Micra to the heart through a catheter inserted into the femoral vein, and securely attach the device to the heart wall using small tines. An electrode at the end of the pacemaker delivers electrical impulses to the heart.
The latest implants build on Medtronic's previous success with the product, as the company implanted its miniature leadless pacemaker in its first U.S. patient in February.
The positive study results also help the company keep a leg up on St. Jude ($STJ), which is hard at work on its own tiny pacemaker system. In February, the Minnesota devicemaker implanted its Nanostim leadless pacemaker in its first U.S. patient, kicking off a pivotal trial for FDA approval. A few weeks later, the company launched a massive postapproval study for its device in Europe, planning to enroll 1,000 patients in 100 centers. Nanostim is also billed as one-tenth the size of existing cardiac pacemakers, and won CE mark approval in 2013.
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