FDA approved a new portfolio of MR-conditional pacemakers
It seems like not that long ago Medtronic was building the world's smallest pacemaker, the Micra, which represented a major leap in pacemaker technology.
But Medtronic is not the type of company to rest on its laurels. The company continues to make noteworthy strides in the heart failure business, most recently with FDA approval of a new platform of MR-conditional quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps).
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Medtronic said the new devices - Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, and Solara Quad CRT-P MRI SureScan - should be available in the United States in early summer. The devices are designed to allow clinicians to provide more personalized therapy options, and patients with one of these pacemakers implanted can receive MRI scans in either 1.5 or 3 Tesla machines.
"The beauty of this device platform is it now brings us into the role of having a quadripolar CRT-P device, as opposed to a defibrillator device, which we've had for some time," David Steinhaus, MD, vice president and general manager of Medtronic's heart failure business, told Qmed.
This CRT-P portfolio received CE mark in February.
Steinhaus said the new platform also includes a chip set that allows the company to iterate on the platform much more quickly than it has been able to do in the past.
"It puts us in the position, both in CRT-D and in CRT-P, where we have absolutely the best products in the industry," Steinhaus said. "And I think even our competition, if they're really being honest with themselves, would say that."
But that's not for lack of effort on the competition's part. Abbott Laboratories, for example, recognized last year that in order to compete with the likes of Medtronic and other leaders of the high-growth cardiovascular device segment, its best strategic move was to combine with St. Jude Medical, a decision that led to Abbott's largest-ever acquisition.
Boston Scientific has also strived to keep up with advancements in pacing technology with products like the ImageReady MR-conditional pacing system that FDA approved in April 2016.
Medtronic's new pacemakers come fully loaded with bells and whistles from the company's CRT-Ds.
The Percepta Quad CRT-P features Medtronic's EffectivCRT Diagnostic, a technology aimed at determining the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during atrial fibrillation, the company noted. It also includes VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes, and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.
The Percepta Quad and Serena Quad CRT-Ps also feature the company's AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59%, and has demonstrated a 46% reduction in AF risk compared to echo-optimized biventricular pacing. Multiple point pacing, which can stimulate the left ventricle (lower chamber) at two sites, is also available on both devices.
All three CRT-Ps also are compatible with Attain Performa MRI SureScan quadripolar leads, which include short bipolar spacing to reduce the occurrence of phrenic nerve stimulation, steroid on all electrodes, and three shapes for varying patient anatomies. The contoured design, which Medtronic calls PhysioCurve, is intended to reduce overall skin pressure compared to non-contoured devices, for enhanced comfort and better cosmetic appearance of the implant site.
"We've been on a journey over the past several years, really, to try to improve how patients do with the CRT pacing," Steinhaus said.
While resynchronization therapy has been able to change the course of heart failure for many patients, there are still patients who could be served even better by more advanced, and more personalized, CRT technology, he said.
"So we've worked hard coming up with a number of different algorithms, which allow us to personalize the pacing therapy to each individual's needs, on a very frequent basis, on a minute-to-minute basis," Steinhaus said. "It allows us then, to get the best out of the pacemaker for the patient."
Amanda Pedersen is Qmed's news editor. Contact her at [email protected].
[Image courtesy of Pixabay]