Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls. A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on its end … [Read more...] about 3 pitfalls to consider when creating catheter delivery systems
Implants
FDA approves Medtronic next-gen Evolut FX TAVR system
Medtronic today announced that its Evolut FX TAVR system has won FDA approval. Fridley, Minn.–based Medtronic designed the self-expanding transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis. The TAVR system uses a supra-annular valve design that has demonstrated hemodynamic performance that is superior to … [Read more...] about FDA approves Medtronic next-gen Evolut FX TAVR system
FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump
Abiomed (NSDQ:ABMD) this week announced that the FDA has granted breakthrough device designation for its Impella ECP expandable percutaneous heart pump. Danvers, Mass.-based Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the … [Read more...] about FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump
FDA approves Abbott Amplatzer Amulet to treat AFib
Abbott this week announced that it has received FDA approval for its Amplatzer Amulet device to treat atrial fibrillation. The Amplatzer Amulet is a left atrial appendage occluder for treating atrial fibrillation (AFib) with a risk of ischemic stroke. The device is a small pouch connected to the upper left chamber of the heart. Get the full … [Read more...] about FDA approves Abbott Amplatzer Amulet to treat AFib
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to … [Read more...] about The 18 most innovative medical devices of 2021
Glaukos wins Australian regulatory approval for MicroShunt
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia's Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or … [Read more...] about Glaukos wins Australian regulatory approval for MicroShunt
How Abbott engineered a catheter-delivered device for premature babies
Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance. The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus … [Read more...] about How Abbott engineered a catheter-delivered device for premature babies
Olympus acquires Israel-based Medi-Tate
Olympus (TYO:7733) announced that it finalized the acquisition of benign prostatic hyperplasia (BPH) treatment developer Medi-Tate. The Japanese conglomerate did not disclose the financial terms of the acquisition, which was finalized after the company exercised a call option in February, according to a news release. Get the full story at our … [Read more...] about Olympus acquires Israel-based Medi-Tate
Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
Micro Interventional Devices today said it received FDA breakthrough device designation for its MIA-T percutaneous tricuspid annuloplasty system. The MIA-T system treats moderate to severe tricuspid regurgitation through a 12F catheter-based system. Micro Interventional Devices studied the safety and performance of the device in a study … [Read more...] about Micro Interventional Devices tricuspid annuloplasty system wins FDA breakthrough device designation
atHeart Medical launches atrial septal defect occluder trial
AtHeart Medical is initiating a U.S. investigational device exemption trial for its atrial septal defects (ASD) occluder. The reSept ASD Occluder is an occluder with a metal-free, bioresorbable frame. The implant is designed to overcome the limitations of occluders by reducing the risk of complications associated with the long-term presence of … [Read more...] about atHeart Medical launches atrial septal defect occluder trial
