Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
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.
Despite the morbidity associated with coronary artery bypass graft, this procedure has never been entirely displaced by percutaneous coronary intervention. The results from the latest in a series of studies does not seem to help the case for drug-eluting stents (DES) for patients with three-vessel disease, as the data from this study failed to demonstrate non-inferiority for DES devices implanted with the help of fractional flow reserve measurement to ensure optimal stent placement.