Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures. The Atlanta-based company will transfer full ownership to Baxter , following a sale agreement that occurred in July 2021. Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. […]
Pre-Market Approval (PMA)
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result […]
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is not approvable. The FDA said it […]
FDA OKs Inspire therapy for younger Down syndrome patients
Inspire Medical Systems (NYSE:INSP) announced today that the FDA has approved its implantable Inspire therapy for pediatric Down syndrome patients. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear [Boston], led by Dr. Christopher Hartnick, have pioneered the use of Inspire in this important group of people, and we […]
Medtronic RDN trial fails to beat hypertension drugs; data submitted for FDA review
Medtronic (NYSE:MDT) said its Symplicity Spyral renal denervation (RDN) system for treating hypertension failed to outperform blood pressure drugs in the latest trial results. However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release. RDN is designed to treat hypertension […]
FDA approves Abiomed Impella RP Flex with SmartAssist for treating right heart failure
Abiomed (Nasdaq:ABMD) announced today that the FDA granted its Impella RP Flex with SmartAssist pre-market approval (PMA). Danvers, Massachusetts-based Abiomed designed the Impella RP Flex with SmartAssist to treat right heart failure. It does so for up to 14 days. The company intends to introduce Impella RP Flex in the U.S. through a controlled launch […]
Abiomed reaches new regulatory milestone for its Impella pumps
Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps. Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps. Impella pumps treat […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Edwards wins FDA approval for Pascal Precision transcatheter valve repair system
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Pascal Precision system for patients with degenerative mitral regurgitation (DMR). The implant and transcatheter delivery system represent Edwards’ bid to compete with Abbott and its MitraClip in the DMR treatment space. Irvine, California-based Edwards Lifesciences designed its Pascal Precision system for precision transcatheter edge-to-edge repair […]
FDA approves AcuFocus intraocular lens for cataract surgery
AcuFocus announced today that it received FDA approval for its IC-8 Apthera intraocular lens for the treatment of cataracts. Irvine, California-based AcuFocus said in a news release that the Apthera IOL represents the first and only non-toric, extended depth of focus IOL approved for the 82% of cataract patients who have as much as 1.5 […]
FDA approves expanded, full-body MRI compatibility with Inspire therapy
Inspire Medical Systems recently announced that FDA has approved additional MRI scan conditions for use with Inspire therapy Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. Company officials in a July 6 news release said the full-body MRI approval expands the Inspire use labeling. […]
