Medtronic (NYSE: MDT) announced today that investigators enrolled the first patient in a pivotal trial of its Prevail drug-coated balloon (DCB). The study evaluates the paclitaxel-coated balloon catheter for in-stent restenosis (ISR) and de novo small vessel disease. Dr. Ziad Ali, director of the DeMatteis Cardiovascular Institute at St Francis … [Read more...] about Medtronic enrolls first patient in drug-coated balloon study
Catheters
Boston Scientific reports first cases with next-gen Faraflex catheter
Boston Scientific today announced the completion of the first-ever cases with its Faraflex mapping and pulsed field ablation (PFA) catheter. This latest technology marks another milestone for the Farapulse PFA portfolio. Boston Scientific initially won FDA approval for Farapulse in January 2024 and has since reported a number of significant … [Read more...] about Boston Scientific reports first cases with next-gen Faraflex catheter
Jabil partners with Midwest Interventional Systems on catheter tech
Jabil and Midwest Interventional Systems (MIS) have entered into a collaborative agreement that will expand what the two contract development and manufacturing organizations can do for medical device developers, including those working on minimally invasive systems. St. Petersburg, Florida-based Jabil and Maple Grove, Minnesota-based MIS said … [Read more...] about Jabil partners with Midwest Interventional Systems on catheter tech
Data backs Lungpacer Medical’s diaphragm neurostim
Lungpacer Medical today announced positive results from a Phase 1 clinical study evaluating its neurostimulation technology platform. The STIMULUS trial investigated the application of diaphragm neurostimulation to improve hemodynamic performance in patients on invasive mechanical ventilation. Results demonstrated improvement in hemodynamic … [Read more...] about Data backs Lungpacer Medical’s diaphragm neurostim
E2 raises $42M Series B
Endovascular Engineering (E2) announced today that it raised $42 million in an oversubscribed Series B financing round. 415 Capital and S3 Ventures co-led the financing round. Panakès Partners, M&L Healthcare and founding investor Santé Ventures also participated. Two global strategic investors made commitments alongside Cordis, which … [Read more...] about E2 raises $42M Series B
Boston Scientific wins CE mark for Farapulse Nav mapping tech
Boston Scientific announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software. Farawave Nav and the Faraview software make up part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January 2024. In doing so, it … [Read more...] about Boston Scientific wins CE mark for Farapulse Nav mapping tech
Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause
This article originally ran on Feb. 15, 2025. It was updated on Feb. 28 with additional information from the FDA. Johnson & Johnson MedTech announced that it intends to resume the rollout of its Varipulse platform in the U.S. after a temporary pause. Last month, the medtech giant said it temporarily halted all U.S. cases using its … [Read more...] about Johnson & Johnson MedTech resumes Varipulse sales after stroke-related pause
Medtronic wins CE mark for jugular dual lumen catheter for young children
A Medtronic official said today on LinkedIn that the company won CE mark for its Crescent RA jugular dual lumen catheter. Giuseppe Savoja, the medtech giant's senior business director for Western Europe, posted the announcement on LinkedIn: "Exciting times! I'm proud and thrilled to announce that the Medtronic Crescent RA jugular dual lumen … [Read more...] about Medtronic wins CE mark for jugular dual lumen catheter for young children
Volta Medical data supports AI-guided ablation for treating AFib
Volta Medical today announced the publication of data highlighting positive outcomes for its AI-guided ablation procedure. Investigators published findings from the landmark TAILORED-AF clinical trial in Nature Medicine. Data demonstrated that an AI-guided procedure for persistent AFib in combination with conventional pulmonary vein isolation … [Read more...] about Volta Medical data supports AI-guided ablation for treating AFib
WhiteSwell has positive fluid removal data
WhiteSwell today announced positive data from 21 patients treated in a trial evaluating its eLym system for fluid removal. The company also announced FDA breakthrough device designation for the system. The agency also accepted it into its Total Product Lifecycle Advisory Program (TAP). Dr. Jan Biegus presented the data at the Technology and … [Read more...] about WhiteSwell has positive fluid removal data
