Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
Robocath SAS is about to embark on a limited market release of its robotic platform, the R-One+, which will not only make performing coronary angioplasties easier and safer but will protect cardiologists from radiation, CEO Lucien Goffart told BioWorld in an interview. However, the launch comes on the heels of a decision by Siemens Healthineers Inc. to discontinue its robotic-assisted endovascular cardiology business as it did not meet the company’s “initial expectations.”
Among the many companies presenting data at the EuroPCR conference in Paris, several late breaking trials from heavy hitters Medtronic plc, Royal Phillips NV and Edwards Lifesciences Corp. stood out.
GE Healthcare Technologies Inc. launched a 3Dstent imaging tool at the EuroPCR conference in Paris which it said will allow a new perspective on stent visualization, helping doctors do a better job. The company warned however that it is still in the process of validating the technology, which complements existing technologies and provides intraprocedural 3D and multi-slice images of stent but has certain limitations.
Heartpoint Global Inc. will begin human trials of its Intellistent device shortly and expects to make submission to the U.S. FDA in 2024, Seth Bogner, its chairman and CEO told BioWorld in an interview on the sidelines of the EuroPCR conference in Paris. Intellistent is a multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. It is a minimally invasive device that will meet an unmet need in pulmonary artery hypertension caused by congenital heart disease, said Bogner.
Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.
Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.
It has become apparent that introducing two stents into the body to treat a patient with a bifurcation disease is not necessary and can be harmful, David Hildick-Smith, the lead investigator in a study, told delegates at the EuroPCR conference in Paris. Presenting late-breaking clinical data of three-year follow up results of different stenting strategies in patients with true left main stem bifurcation lesions, Hildick-Smith said that the results showed that only one in five patients needed a second stent.
Creative Balloons GmbH has changed its name to Advanced Medical Balloons GmbH and is bringing its fecal management system, Hygh-tec, to the U.S. market after receiving clearance from the U.S. FDA. Hygh-tec is a microscopically thin polyurethane balloon catheter system which enables reliable, sealed access to the colon preventing fecal leakage from patients in intensive care units.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
