Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a collaboration with CardioNXT to support its AFib treatment. The collaboration supports Pulse Biosciences' planned first-in-human study of its pulsed-field ablation technology. Hayward, California-based Pulse develops a proprietary nanosecond pulsed-field ablation (nsPFA) … [Read more...] about Pulse Biosciences, CardioNXT to collab on pulsed-field ablation trial
Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B
MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing … [Read more...] about Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B
PercAssist treats first patient in heart failure support trial
PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study. The study evaluates PercAssist's minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients. Principal investigator Dr. Petr Neuzil completed the first case at … [Read more...] about PercAssist treats first patient in heart failure support trial
FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system. The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures. According to a news release, all cardiovascular procedures cause the … [Read more...] about FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
Zeus launches next-gen tubing for bioresorbable vascular scaffolds
Zeus announced today that it launched the newest member of its family of bioabsorbable products: Absorv XSE oriented tubing. Orangeburg, South Carolina-based Zeus designed Absorv XSE as a highly customizable platform for design. Available in a variety of resins and expanded size ranges, it offers an alternative to metallic products … [Read more...] about Zeus launches next-gen tubing for bioresorbable vascular scaffolds
Biosense Webster begins Omnypulse pulsed-field ablation trial
Johnson & Johnson's Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard … [Read more...] about Biosense Webster begins Omnypulse pulsed-field ablation trial
CereVasc wins FDA IDE to expand eShunt trial
CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in … [Read more...] about CereVasc wins FDA IDE to expand eShunt trial
Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million. Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support … [Read more...] about Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
FDA approves LimFlow chronic limb-threatening ischemia treatment
LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI). Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition. France-based … [Read more...] about FDA approves LimFlow chronic limb-threatening ischemia treatment
Gradient Denervation raises $15M Series A for catheter tech
Gradient Denervation Technologies announced that it closed a $15 million (€14 million) Series A financing round. Paris-based Gradient develops a catheter-based solution for treating pulmonary hypertension. It expects the financing to support the ongoing clinical development and evaluation of the ultrasound-based device. Asabys Partners led … [Read more...] about Gradient Denervation raises $15M Series A for catheter tech