HomeMEDTRONIC plcMedtronic Receives FDA Approval for Trial Evaluatiing New Energy Source with Pulsed Electrical Fields to Treat Afib

Medtronic Receives FDA Approval for Trial Evaluatiing New Energy Source with Pulsed Electrical Fields to Treat Afib

Medtronic has announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. First procedures in the trial were performed in December 2019 by Bradley Wilsmore, M.D., at John Hunter Hospital, New Lambton Heights, NSW, Australia and in January by Atul Verma, M.D., the principal investigator (PI) for the study, at Southlake Regional Health Centre in Newmarket, Canada.

Medtronic reports PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt irregular electrical pathways in the heart and the triggers of atrial fibrillation. However, unlike traditional methods of ablation that heat the tissue (radio frequency) or cool the tissue (cryo) to ablate, PFA is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue.

“This study will evaluate a new energy source that may treat atrial fibrillation and potentially address the risks that have been associated with other ablation technologies, such as unintended tissue damage,” said Verma. “The rigorous pre-clinical research to get us to these first procedures has been impressive and we are excited to support the development of more clinical evidence.”

In September 2018, Medtronic was granted Breakthrough Device designation from the FDA for the PFA technology for the treatment of drug-refractory recurrent symptomatic atrial fibrillation. Worldwide, the PFA system is investigational and not approved for sale or distribution.

PULSED AF is a prospective, multi-center, non-randomized, unblinded and worldwide study that will enroll patients who will be treated with the Medtronic PulseSelect PFA System.

“As a global leader in the treatment of cardiac arrhythmias, Medtronic is constantly evaluating new and existing therapies to better meet the needs of patients and the physicians who care for them,” said Rebecca Seidel, vice president, and general manager in the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic. “The PULSED AF study is another example of our commitment to meaningful innovation and a major step forward in the development of a diverse set of therapy options for atrial fibrillation patients.”

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 of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

Skyhawk Therapeutics Completes New Investment Round

A $133 million round of investment will allow Skyhawk to accelerate development of its novel small molecule RNA-modifying drug candidates into the clinic.

By using this website you agree to accept Medical Device News Magazine Privacy Policy