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Xeltis, a Swiss-Dutch clinical-stage medical device company, recently announced that three pediatric patients have been successfully implanted with the world’s first heart valve enabling cardiovascular restoration. The children have been enrolled in the “Xplore-I” clinical study of Xeltis bioabsorbable pulmonary heart valve, a multi-centered feasibility trial currently enrolling pediatric patients from 2 to 21 years of age in leading heart centers in Europe.
The company’s pulmonary valve works like commonly available prosthetic heart valves, but thanks to the firm’s Endogenous Tissue Restoration (ETR) technology, the device allows patients’ own cells to penetrate it and make home there. As natural tissue takes over, the valve itself slowly degrades and is absorbed by the body. The result is a naturally reconstructed heart having no foreign materials.
The primary objective of the Xplore-I clinical feasibility study is to assess the survival rate of patients undergoing Right Ventricular Outflow Tract (RVOT) reconstruction at six months following implantation of the bioabsorbable heart valve. RVOT reconstruction is an open-heart surgery often involving pulmonary heart valve replacement. It is normally performed in children born with congenital heart defects. The first three trial implants have been conducted at Gottsegen György Hungarian Institute of Cardiology’s Pediatric Cardiac Centre in Budapest (Hungary) and University Children’s Hospital in Krakow (Poland).
“The Xplore-I patients are doing well and have been discharged from hospital,” said Dr. Zsolt Prodan, M.D., Head of Congenital Heart Surgery at Paediatric Cardiac Centre in Budapest, who performed the first two interventions in July. “The bioabsorbable implant is performing according to expectations,” he added. Dr. Prodan will present trial details at the 30th Annual Meeting of the European Association of Cardio-Thoracic Surgery (EACTS) on Tuesday, October 4.
“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,” stated Thierry Carrel, M.D., principal investigator of the ‘Xplore-I’ study, and Professor of Surgery at the Clinic for Cardiovascular Surgery, University Hospital Bern (Switzerland). “We are quite confident regarding this technology, since children from the precursor feasibility study on bio-absorbable blood vessels demonstrate excellent results over two years after implantation,” he continued.
“Initiating the clinical trial on our first 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,” Laurent Grandidier, Xeltis CEO. “We are reinventing the heart valve with the goal of making better solutions available to patients,” he added.
For Further Information
More on the European markets for cardiac surgery and heart valve devices can be found in the 2014 edition report published by iData entitled European Markets for Cardiac Surgery and Heart Valve Devices, which covers 15 countries in Europe, as well as market segments for the following: tissue heart valves, mechanical heart valves, annuloplasty repair, transcatheter mitral valve repair, transcatheter heart valve implantation, on-pump coronary artery bypass, off-pump coronary artery bypass, endoscopic vessel harvesting, anastomosis assist, cardiac ablation, transmyocardial revascularization, ventricular assist, intra-aortic balloon pumps, artifical hearts, patent foramen ovale, and atrial and ventricular septal devices.
Recent reports on the markets for cardiac surgery and heart valve devices cover the U.S. and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a European Markets for Cardiac Surgery and Heart Valve Devices report brochure and synopsis.
About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Dental Operatory Equipment, X-Ray Imaging, Vascular Access, Peripheral Vascular, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Diagnostic Imaging, Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Oncology, Ultrasound, Laparoscopy, Urology, Gynecology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large and Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics and more.
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