Boston Scientific (NYSE: BSX) announced today that the FDA approved an expansion to the label of its Farapulse pulsed field ablation (PFA) system. Farapulse, one of the leading PFA systems for treating AFib, received a much-anticipated FDA approval last year. The system treats AFib by delivering pulsed field energy through a catheter to ablate … [Read more...] about Boston Scientific wins expanded FDA nod for Farapulse PFA
Applications
Stereotaxis shares data supporting Magic catheter
Stereotaxis (NYSE:STXS) announced the publication of initial clinical results using its MAGiC robotic magnetic navigation catheter. The results, published in the Journal of Interventional Cardiac Electrophysiology, mark the first peer-reviewed literature supporting the efficacy and safety of MAGiC. MAGiC, a robotically navigated magnetic ablation … [Read more...] about Stereotaxis shares data supporting Magic catheter
Kardium raises $250M to support pulsed field ablation system
Kardium announced today that it raised $250 million in a new financing round to support the launch of its pulsed field ablation system. New investors, including Janus Henderson Investors, Qatar Investment Authority (QIA), MMCAP, Piper Heartland Healthcare Capital, Eventide Asset Management and Eckuity Capital, led the oversubscribed round. … [Read more...] about Kardium raises $250M to support pulsed field ablation system
Field Medical raises $35M Series B to support pulsed field ablation tech
Field Medical announced today that it closed a Series B funding round worth proceeds totaling $35 million. BioStar Capital and Cue Growth led the round, which had participation from existing strategic investors, too. This funding adds to a $40 million Series A brought in earlier this year and brings the Cardiff-by-the-Sea, California-based … [Read more...] about Field Medical raises $35M Series B to support pulsed field ablation tech
Acutus to sell electrophysiology assets to EnChannel
EnChannel Medical announced today that it agreed to acquire the AcQMap platform assets from Acutus Medical. This deal centers around the AcQMap high-resolution imaging and mapping platform from Acutus. It also includes substantive intellectual property, quality and regulatory documentation and clinical data. With the agreement, EnChannel receives … [Read more...] about Acutus to sell electrophysiology assets to EnChannel
Teleflex completes acquisition of Biotronik’s Vascular Intervention business
Teleflex [WtwhTicker symbol="TFX"](NYSE: TFX)[/WtwhTicker] announced today that it completed its previously announced acquisition of the Biotronik Vascular Intervention (VI) business. As part of strategy shifts by both companies, Teleflex in February agreed to acquire substantially all of the Biotronik VI unit. The acquisition adds a broad … [Read more...] about Teleflex completes acquisition of Biotronik’s Vascular Intervention business
InterShunt enrolls first patient in heart failure treatment study
InterShunt Technologies announced today that it has begun an early feasibility study of its device for reducing symptoms of heart failure. Dr. Sitaramesh Emani and the Structural Heart Intervention Team at The Christ Hospital Health Network in Cincinnati, performed the first procedure utilizing the technology. The study focuses on patients with … [Read more...] about InterShunt enrolls first patient in heart failure treatment study
Circa completes limited launch of transseptal access system
Circa Scientific announced that it completed the limited market release for its CrossWise RF transseptal access system. Englewood, Colorado-based Circa designed its zero-exchange RF system to deliver energy through a purpose-built cannula. The cannula maintains shape and stability during septal crossing. This approach allows for deliberate control … [Read more...] about Circa completes limited launch of transseptal access system
Cook Medical angiographic catheter recall is Class I
The FDA has designated Cook Medical's recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the most serious level. Users reported tip separation occurring both before and during patient contact, according to an FDA notice published today. As a result, catheter fragmentation and embolization might occur with the catheters involved in … [Read more...] about Cook Medical angiographic catheter recall is Class I
FDA grants PMA for InspireMD CGuard Prime carotid stent, triggers $18M milestone payment
InspireMD announced that the FDA granted premarket approval (PMA) for its CGuard Prime carotid stent system. The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark earlier this month. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term … [Read more...] about FDA grants PMA for InspireMD CGuard Prime carotid stent, triggers $18M milestone payment
