Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
Three-year data from Elixir Medical Corp.’s Bioadaptor randomized controlled trial showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system continued to see lower adverse events rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent .
Shockwave Medical Inc., a unit of Johnson & Johnson Medtech, reported positive 30-day results from the EMPOWER CAD trial, which used its intravascular lithotripsy system in women with complex, calcified coronary artery disease. The results from the first prospective, real-world percutaneous coronary intervention study in female patients confirmed the benefit of coronary patients as seen in other retrospective analyses.
Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.
Elixir Medical Corp. reported positive 12-month clinical data from the Desyne BDS Plus randomized controlled trial which evaluated its Desyne BDS plus system, a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating, against a contemporary, durable polymer drug-eluting stent in the treatment of de novo native coronary artery lesions.
One-year data from the Notion-2 trial, which compared transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) in younger low-risk patients with severe tricuspid or bicuspid aortic valve stenosis, showed little difference in clinical outcomes between the two procedures. The results were presented at the recent EuroPCR conference in Paris.
Data from Meril Life Sciences Pvt Ltd.’s Landmark trial showed that its series of Myval transcatheter heart valves were non-inferior compared with Edwards Lifesciences Corp.’s Sapien BEV and Medtronic plc’s Evolut SEV devices, with regards to safety and effectiveness in patients undergoing transcatheter aortic valve implantation.
Elixir Medical Corp. revealed that data from the Pinnacle I study has validated the safety and effectiveness of its Lithix Hertz contact intravascular lithotripsy system to treat moderate to severe calcified coronary artery lesions by percutaneous transluminal coronary angioplasty.
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.