Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Pulsed Field Ablation

Johnson & Johnson MedTech wins FDA nod for Varipulse PFA

By

Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies … [Read more...] about Johnson & Johnson MedTech wins FDA nod for Varipulse PFA

Johnson & Johnson completes pilot enrollment in Omnypulse trial

By

Johnson & Johnson MedTech today announced the completed enrollment of the pilot phase of a clinical trial for its Omnypulse platform. The OMNY-AF clinical trial evaluates the investigational platform for the treatment of symptomatic paroxysmal AFib in the U.S. and Australia. The single-arm, multi-center trial completed the pilot phase … [Read more...] about Johnson & Johnson completes pilot enrollment in Omnypulse trial

Johnson & Johnson reports first commercial Varipulse PFA use in Canada

By

Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] today announced the first completed commercial case with its Varipulse platform in Canada. The company said in a post on LinkedIn that doctors at the Ottawa Heart Institute completed the first commercial case with Varipulse. Johnson & Johnson said the procedure … [Read more...] about Johnson & Johnson reports first commercial Varipulse PFA use in Canada

Abbott progresses pulsed field ablation studies, launches cardiac mapping tool

By

Abbott today announced new milstones supporting its suite of pulsed field ablation (PFA) solutions in electrophysiology. The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, … [Read more...] about Abbott progresses pulsed field ablation studies, launches cardiac mapping tool

J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan

By

Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company's Omnypulse platform. The J&J unit designed … [Read more...] about J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan

How Medtronic designed the PulseSelect pulsed field ablation system for AFib

By

Medtronic‘s PulseSelect became the first pulsed field ablation (PFA) system to win FDA approval for treating atrial fibrillation (AFib) in December 2023. The world’s largest medical device manufacturer achieved that milestone about 15 years after one of its engineers, Mark Stewart, coined the term “pulsed field ablation” in a research paper … [Read more...] about How Medtronic designed the PulseSelect pulsed field ablation system for AFib

Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial

By

Field Medical announced today that it began the first-in-human study of its FieldForce pulsed field ablation (PFA) system. The company began its study evaluating FieldForce at Na Homolce Hospital in Prague, Czech Republic. It expects the VCAS study to enroll up to 60 patients at up to five sites around the world. Cardiff-by-the-Sea, … [Read more...] about Farapulse founder’s Field Medical begins first-in-human pulsed field ablation trial

First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks
The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that's unique within Medtronic's PFA device portfolio.

By

Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world's largest device manufacturer. In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac … [Read more...] about First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks

Thermedical completes feasibility study to use SERF with PFA

By

Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system. Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT). According to Thermedical, SERF (saline-enhanced radio … [Read more...] about Thermedical completes feasibility study to use SERF with PFA

The top catheter-based innovation news stories of 2024 — so far

By

Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies entering the space. Intravascular lithotripsy is having its moment as well – Shockwave Medical was … [Read more...] about The top catheter-based innovation news stories of 2024 — so far