The Dutch-Swiss company, which won humanitarian use device status from the FDA in March, said the feasibility study is designed to evaluate the 6-month survival rate using the valve in patients during right ventricular outflow tract procedures. Three patients implanted with the device in Hungary and Poland have been discharged and are doing well, according to Dr. Zsolt Prodan, the surgeon who performed 2 of the open heart procedures in July.
“The bioabsorbable implant is performing according to expectations,” Prodan, of Budapest’s Gottsegen György Hungarian Institute of Cardiology, said in prepared remarks. He is due to present details on the trial tomorrow at the annual meeting of the European Assn. of Cardio-Thoracic Surgery in Barcelona.
“Reconstruction and replacement of diseased heart valves in children using patients’ own tissue could help reduce the risk of complications and of re-interventions observed with animal and human donor implants,” added principal investigator Dr. Thierry Carrel of Switzerland’s University Hospital Bern. “We are quite confident regarding this technology, since children from the precursor feasibility study on bio-absorbable blood vessels demonstrate excellent results over 2 years after implantation.”
“Initiating the clinical trial on our 1st bioabsorbable heart valve is a pivotal event for Xeltis. The extensive number of presentations on our technology at this year’s EACTS meeting confirm our company’s fast advancement,” CEO Laurent Grandidier said in a press release. “We are reinventing the heart valve with the goal of making better solutions available to patients.”
Last December, Zurich- and Eindhoven, Holland-based Xeltis added $3.2 million (EU €3 million) to a Series B round, bringing the total to $32.4 million (€30 million).
The post Xeltis launches bioresorbable heart valve study appeared first on MassDevice.
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