First Enrollments in the TactiFlex PAF IDE Study Underway

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

The TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation, a type of irregular heartbeat is underway. The news was announced by Abbott today.

The study will evaluate the performance of the investigational TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for people whose atrial fibrillation (AFib) symptoms are unable to be managed by medication.

More than 16 million people globally are impacted by recurrent AFib, episodes of sporadic, irregular heartbeats when the heart’s upper chambers beat out of sync with the lower chambers. People suffering from AFib face a number of challenges to their quality of life, including episodes of dizziness, fatigue, and shortness of breath. Long term, they also face an increased risk of stroke or heart failure.

The TactiFlex PAF IDE study will enroll 355 patients at multiple sites worldwide. Patients enrolled in the trial will receive an ablation procedure using Abbott’s TactiFlex Ablation Catheter, SE. Data collected from the study will be submitted to support global regulatory approvals.

Physicians use tools, such as contact force technology, during ablation procedures to help them apply the right amount of pressure to the heart tissue to improve procedural effectiveness. Additionally, physicians use magnetically sensor enabled technology, such as the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, for precise location and navigation within the heart.

“The TactiFlex device builds on prior generations of successful technology, giving me confidence that Abbott will continue providing options to effectively treat people living with recurrent episodes of atrial fibrillation,” said Prof. Prash Sanders, director of Centre for Heart Rhythm Disorders at The Royal Adelaide Hospital in Adelaide, South Australia.

The start of the TactiFlex PAF IDE trial is among a series of product-focused activities from Abbott designed to improve patient care and meet the needs of electrophysiologists around the world. The company also recently secured U.S. Food and Drug Administration (FDA) and CE Mark approval for the EnSite™ LiveView Dynamic Display. LiveView is designed to allow data from the Advisor HD Grid mapping catheter to be visualized in real-time during cardiac ablation procedures. The Advisor HD Grid catheter is designed to capture information often missed with traditional mapping catheters.

“Abbott is focused on bringing innovation to physicians that can improve how people with atrial fibrillation are treated. The TactiFlex Ablation Catheter, SE brings the best of Abbott’s ablation technologies into a single catheter,” said Mike Pederson, senior vice president of Abbott’s electrophysiology and heart failure businesses.

The TactiFlex Ablation Catheter, SE is being clinically evaluated as part of the TactiFlex PAF IDE – a global study – and is not yet commercially available.

 

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles