Lattice Medical SAS reported the first successful breast reconstruction using Mattisse technology, a totally resorbable, 3D-printed implant which naturally regenerates fatty tissue. The procedure was performed at the Institute of Clinical Oncology in Tbilisi, Georgia. It was the work of cancer specialist Gia Nemsadze and his team. This was an immediate breast reconstruction for a 62-year-old patient with breast cancer. The surgical procedure lasted one and a half hours, allowing the mastectomy to be completed, immediately followed by the breast reconstruction.
Limacorporate SpA reported U.S. FDA approval for Prima, its new shoulder platform focused on versatility and operating roam efficiency. “For the first time in our history, both the glenoid base plate and humeral stem are fully 3D-printed, leveraging our long legacy in additive manufacturing,” Massimo Calafiore, CEO of Limacorporate, told BioWorld.
Getinge AB reported a partnership with Medtronic plc for the Radiant stent, the first covered stent indicated for chimney endovascular aneurysm repair (ChEVAR). This new balloon-expandable stent graft for renal arteries obtained CE mark approval on Sept. 20.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
Tricares SAS raised $47 million in a first closing of its series C financing to fund further development of Topaz, its minimally invasive treatment for tricuspid regurgitation. The completion of the series C financing round is expected later in 2022.
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.