Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms.
A tissue engineered polymer wrap designed to reduce vein graft failure rates in patients on hemodialysis for chronic kidney disease (CKD) has won FDA breakthrough device designation. Developed by Houston-based Venostent Inc., the Selfwrap bioabsorbable perivascular wrap is macroporous material that wraps around blood vessels and acts as a scaffold to ensure veins and arteries work together seamlessly to filter out toxins in the patient’s blood.
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology.
Medtronic plc has unveiled its latest buy this year with the planned acquisition of Avenu Medical Inc., which focuses on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. The two did not disclose the terms of the transaction.
Medtronic plc is highlighting the publication of primary endpoint results from the In.Pact AV Access trial in the New England Journal of Medicine. The study found that the company’s paclitaxel-coated balloon limits the number of reinterventions needed to maintain blood flow in patients with end-stage renal disease who have arteriovenous fistulae.