UPDATED: FDA approves first leadless transcatheter pacemaker for Medtronic, St. Jude up next

Micra Transcatheter Pacing System--Courtesy of Medtronic

Medtronic has won the first U.S. approval for a leadless pacemaker from the FDA. The inch-long device is the smallest available and is implanted directly into the heart's right ventricle chamber. Traditional pacemakers require wired leads to connect the device to the heart. The news comes after an FDA panel earlier this year that considered the prospects for the entire category of leadless pacemakers, including one from St. Jude Medical.

The device, the Micra Transcatheter Pacing System, is introduced into the body via catheter rather than requiring surgical implantation--making the introduction of a pacemaker a minimally invasive process. It adjusts and responds to an individual patient's heart rate and stimulates it accordingly.

Pacemaker leads can be problematic for patients since they can malfunction or cause infection in the surrounding tissue, which requires surgical replacement. Typically, a traditional, single-chamber pacemaker is implanted near the patient's collarbone and runs through a vein into the heart's right ventricle, thereby delivering electric pulses to regulate the heart rate.

"As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads," said Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, in a statement.

Almost one million people globally receive implanted pacemakers. Leadless pacemakers are expected to cause a significant shift in the more than $3 billion market for traditional pacemakers. The newly approved Micra Transcatheter Pacing System from Medtronic ($MDT) as well as St. Jude's ($STJ) leadless pacemaker, Nanostim, each already have CE marks and are sold in Europe.

Micra is approved by the FDA for atrial fibrillation patients, as well as patients with other dangerous heart arrhythmia conditions such as bradycardia-tachycardia syndrome. The device isn't indicated for patients with other implanted devices that might interfere with it, for severely obese patients, for those with an intolerance to the device materials, for those on the blood thinner heparin or those with veins are too small to accommodate the introducer sheath or the implant itself.

There are already more than 30 U.S. centers trained in Micra implementation due to their clinical trial participation, Medtronic told FierceMedicalDevices via email. A limited launch is slated for late April or early May via these clinical trial sites.

Medtronic will start training additional physicians on the procedure at the Heart Rhythm Conference in San Francisco, CA in early May. A full product launch is slated to follow soon after.

The 719-patient pivotal trial for Micra found that 98% of subjects had adequate heart pacing at 6 months after device implantation. Complications, such as prolonged hospitalizations, deep vein thrombosis, pulmonary embolism, heart injury, device dislocation and heart attacks, occurred in less than 7% of the subjects.

"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 Dr. Dwight Reynolds, chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center and principal investigator in the Micra pivotal 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."

- here is the FDA release
- and detailed FDA product information
- as well as the Medtronic statement