Shockwave Medical announced today that it unveiled a new coronary intravascular lithotripsy (IVL) catheter in the U.S. The planned introduction of the Shockwave C2+ coronary IVL catheter follows the receipt of FDA approval. This catheter offers 50% more pulses per catheter than the Shockwave C2 catheter that the FDA approved in June … [Read more...] about Shockwave Medical launches new coronary IVL catheter following FDA approval
Cordis applauds Medicare expansion for carotid stenting
Cordis announced today that it supports a new expanded coverage decision from the Centers for Medicare & Medicaid Services (CMS). The expanded CMS coverage widens access to minimally invasive endovascular carotid therapy for patients with carotid artery disease. Cordis develops the Precise Pro Rx carotid stent system for this therapy. In a … [Read more...] about Cordis applauds Medicare expansion for carotid stenting
WhiteSwell fluid removal system produces positive study results
WhiteSwell announced positive initial results from its DELTA-HF trial evaluating its eLym system for excess fluid removal. Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). It presented data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio. The … [Read more...] about WhiteSwell fluid removal system produces positive study results
Biosense Webster: catheter ablation leads to lower heart failure risk in AFib patients
Johnson & Johnson's Biosense Webster today announced data supporting the use of catheter ablation in AFib patients. The study, funded by the Irvine, California-based company, looked at heart failure incidence risks in AFib patients. It compared the use of catheter ablation versus antiarrhythmic drugs (AAD). Looking at non-specific catheter … [Read more...] about Biosense Webster: catheter ablation leads to lower heart failure risk in AFib patients
Shifamed’s Akura Medical raises $35M for thrombectomy system
Akura Medical, a Shifamed portfolio company, today announced the closing of a $35 million Series B financing round. Los Gatos, California-based Akura develops a differentiated approach to address the challenges of venous thromboembolism (VTE). The company earmarked the funds for supporting its FDA 510(k) clearance submission for the Akura … [Read more...] about Shifamed’s Akura Medical raises $35M for thrombectomy system
Pulse Biosciences, CardioNXT to collab on pulsed-field ablation trial
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