PARADIGM Pivotal Trial of Anteris’ DurAVR THV Cleared in Germany

October 22, 2026—Anteris Technologies Global Corp. announced that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices to conduct the PARADIGM global pivotal trial of the company’s DurAVR transcatheter heart valve (THV) to treat patients with severe calcific aortic stenosis.

Teleflex Freesolve RMS Receives FDA Breakthrough Device Designation 

October 22, 2026—Teleflex Incorporated announced that the FDA has granted Breakthrough Device designation for its Freesolve resorbable magnesium scaffold (RMS) for percutaneous coronary intervention.

FDA Clear Elucid’s Biointegrated FFR-IQ Software for Coronary CTA

October 21, 2026—Elucid, a developer of artificial intelligence (AI)–powered cardiovascular imaging software, announced FDA 510(k) clearance of its FFR-IQ software for noninvasive estimation of fractional flow reserve from coronary CTA (FFR-CT).

Edwards Pascal Precision System Approved by FDA for Tricuspid Valve Repair

October 21, 2026—Edwards Lifesciences Corporation announced that the FDA has approved its Pascal Precision system for tricuspid valve repair.

SPIRARE II Results Published for Jupiter’s Vertex Thrombectomy System

October 20, 2026—Jupiter Endovascular, Inc. announced that the full results of the SPIRARE II pivotal trial, evaluating the company’s Vertex thrombectomy system in patients with acute, intermediate-risk pulmonary embolism (PE), were published in EuroIntervention by Sameh Sayfo, MD, et al.

Johnson & Johnson’s Shockwave C2 Aero Fly Coronary IVL Catheter Launched in United States

October 20, 2026—Johnson & Johnson announced the United States launch of its Shockwave C2 Aero Fly coronary intravascular lithotripsy (IVL) catheter, which is designed to treat a broad range of calcified coronary artery lesions.

FDA Approves Haemonetics PerQseal Elite Vascular Closure System

October 20, 2026—Haemonetics Corporation announced FDA approval of the PerQseal Elite vascular closure system for large-bore arterial procedures.

HI-PEITHO Analysis Studies Predictors of Major Bleeding in Acute Intermediate-Risk PE

October 16, 2026—A post hoc analysis of the randomized HI-PEITHO study examined potential predictors of major bleeding in patients with acute intermediate-risk pulmonary embolism (PE) treated with ultrasound-facilitated catheter-directed thrombolysis (USCDT) using the Ekos endovascular system (Boston Scientific Corporation) plus anticoagulation (AC) or anticoagulation (AC) alone.