Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
Abbott Laboratories snagged a CE mark for its Volt pulsed field ablation catheter for atrial fibrillation several months earlier than the mid-year approval expected. The Abbott Park, Ill.-based company has begun Volt’s commercial launch with the physicians who participated in its European clinical trials and plans to expand to other users on the continent in the second half of 2025.
The U.S. FDA has posted several class I recalls in recent days, including a removal of one model of the Medtronic Vascular’s Pipeline Vantage embolization device due to insufficient apposition to the vessel wall.
The U.S. FDA’s latest draft guidance on pulse oximeters drew comment from the International Standards Organization and the International Electrotechnical Commission, which are making the case that in addition to differences in pigmentation, the pulsatility of the tissue in contact with the device is also a factor in device performance.
Medtronic plc reported results from a registry highlighting the effectiveness of the Prevail paclitaxel-coated balloon. The findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) were presented by Sacharias von Koch of the department of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden at the Cardiovascular Research Technologies 2025 meeting in Washington.
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
Boston Scientific Corp. agreed to acquire Sonivie Ltd., developer of a therapeutic intravascular ultrasound system for denervation to treat resistant hypertension, pulmonary hypertension and chronic obstructive pulmonary disease. On a 100% basis, the deal is valued at $600 million with $400 million up front and $200 million upon achievement of a regulatory milestone.
Tandem Diabetes Care Inc. reported that its next-generation automated insulin delivery algorithm, Control-IQ+ technology (Control-IQ+), is cleared by the U.S. FDA for use by people with type 2 diabetes (T2D) ages 18 and older.
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
The U.S. FDA’s device center hasn’t issued news bulletins or guidances in the past week, but the march of device recalls continues apace in the month of February.
