Medtronic today announced positive clinical trial data for its Sphere-360 investigational pulsed field ablation (PFA) catheter technology. The single-shot mapping and ablation catheter uses pulsed field energy to treat patients with paroxysmal AFib. Medtronic presented interim findings on the system at the European Heart Rhythm Association (EHRA) 2024 Annual Meeting. Designed with the goal to […]
Catheters
Boston Scientific begins trial of Faraview PFA software with magnetic nav catheter
Boston Scientific announced today that it began a new study of its Faraview software module for the Farawave pulsed field ablation (PFA) catheter. The NAVIGATE-PF study evaluates Faraview when used to visualize and track the Farawave Nav PFA catheter for treating AFib. Faraview and the Farawave Nav catheter expand the capabilities of the Boston Scientific […]
FDA says recall of Cerenovus catheter guide sheaths is serious
The FDA deemed a recall of catheter guide sheaths from Johnson & Johnson’s Cerenovus Class I, the most serious kind. Medos International Sàrl, a J&J unit, recalled the Cerenovus Cerebase DA guide sheath and single-use neurovascular guide catheter on Feb. 2, 2024. The company distributed the devices — 1,343 in total — between June 14, […]
FDA clears AngioDynamics’ AlphaVac F18 to treat pulmonary embolism
AngioDynamics this week announced it received FDA 510(k) clearance for its AlphaVac F18 system to treat pulmonary embolism (PE). The expanded FDA indication allows for the use of AlphaVac F18 system for the treatment of PE. The new indication expands the device’s use in the non-surgical removal of thrombi or emboli from the venous vasculature. […]
Silk Road launches next-gen transcarotid neuroprotection system
Silk Road Medical (Nasdaq:SILK) announced that it launched its EnRoute Plus transcarotid neuroprotection system. The transcarotid artery revascularization (TCAR) system builds upon the company’s previous EnRoute system, launched just last month. It delivers smoother arterial sheath insertion, greater flow precision and a simplified prep experience for surgical teams. The system delivers all this while maintaining […]
Shockwave Medical is reportedly a J&J acquisition target
Shockwave Medical could get acquired by Johnson & Johnson , according to a Wall Street Journal report. WSJ cited people familiar with the matter. They said the acquisition talks, if successful, could result in a finalized deal in the coming weeks. Another suitor could also seek a merger with Santa Clara, California–based Shockwave. The WSJ […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
J&J’s Abiomed has a Class I Impella labeling recall with 49 deaths related to issue
The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind. Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart. This recall (a correction and not a product removal) affects 66,390 Impella pumps […]
Autonomix completes first procedures in pancreatic cancer ablation trial
Autonomix Medical announced today that it completed the first three patient procedures in a proof-of-concept trial of its ablation technology. The Woodlands, Texas-based Autonomix designed its transvascular radiofrequency (RF) ablation technology to treat pancreatic cancer pain. Current approaches to treat this pain include opioids or ethanol injections. However, Autonomix says those approaches may only provide […]
Inari Medical has positive ClotTriever data
Inari Medical announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system. Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum. Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a […]
Boston Scientific has positive Agent DCB study results
Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]