EINDHOVEN, Netherlands & ZURICH – (BUSINESS WIRE) –Xeltis, a clinical-stage company with the most advanced polymer-based restorative cardiovascular devices, today announced the start of the first-ever regulatory study for a synthetic pulmonary restorative valve. To date, pediatric patients in need of right ventricular outflow tract (RVOT) reconstruction have been successfully implanted in the global, FDA-cleared Xplore2 / Pivotal study. RVOT reconstruction is a procedure required to correct certain congenital heart defects.
After implantation, the synthetic restorative pulmonary heart valves from Xeltis develop into fully functional, natural heart valves through colonization with the patient’s own tissue. The porous microstructure of the implants allows the patient’s own tissue to colonize it and naturally form a new heart valve that takes over its function over time. Meanwhile, the original synthetic structure made of electrospun polymers is being reabsorbed by the body.
“Living heart valve regeneration in patients in need of RVOT reconstruction can dramatically change their quality of life,” said David Morales, MD, director, Congenital Heart Surgery, Cincinnati Children’s Hospital and professor, Department of Pediatrics, University of Cincinnati, who as Global Principal Investigator is engaged in the process. “A device that has a longer lifespan and potentially grows with the patient would reduce repeated interventions and the associated physical and psychological stress.”
Xplore2 / Pivotal is a prospective, non-randomized clinical trial evaluating the safety and effectiveness of the pulmonary restorative valve in up to 50 patients undergoing RVOT reconstruction. The US FDA-approved study for the approval of test devices is carried out in up to 15 centers in the US, Europe and Asia. The implanted patients are followed up for five years.
“The data from 18 patients implanted with the Xeltis Restorative Pulmonary Valve in other ongoing clinical trials are very promising,” said Professor Tomasz Mroczek, cardio-thoracic surgeon at the Polish-American Children’s Hospital in Krakow, Poland. Professor Mroczek implanted the first patient in the Xplore2 / Pivotal study and had previously implanted three pediatric patients for the Xeltis pulmonary valve as part of the ongoing Xplore 1 study. “The positive safety profile and performance observed in over 60 patient years of follow-up are strong indications of a potentially best device to reduce re-operations and improve patient lives.”
The two-year results of the Xplore-1 study, which was conducted in 12 patients in Europe and Asia, and the one-year data from the US FDA-approved early feasibility study (EFS) Xplore-2 in six patients were recently in the peer group -Study published -reviewed journal Frontiers in Cardiovascular Medicine.1 Further results from patients up to four years after surgery confirm consistently low re-intervention rates and offer promising evidence of the technology’s superior potential.2
“The Xeltis pulmonary heart valve is the most advanced heart valve with regenerative properties based solely on a biocompatible synthetic structure and the first synthetic restorative valve to be included in a pivotal study,” said Eliane Schutte, CEO of Xeltis. “We are very proud of the progress in our clinical program, which also includes two applications for small diameter blood vessels. All of our regenerative devices promise to offer solutions that overcome the limits of existing technologies – or their complete lack. ”
In addition to its pulmonary restorative valve, Xeltis has developed the very first restorative synthetic coronary artery bypass graft (CABG), which has shown successful long-term results in long preclinical studies, and the very first restorative synthetic vascular access graft for patients in need of dialysis
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Notes for editors
About RVOT
One in 100 babies in the United States is born with a heart defect.3,4 Congenital heart disease (CHD) is the most common type of birth defect5, of which 15-20 percent generally affect the right ventricular outflow tract (RVOT). 2 These defects reduce or stop blood flow to the pulmonary arteries and include serious conditions such as Fallot’s tetralogy, trunk arteriosus, pulmonary atresia, transposition of the great arteries, and pulmonary stenosis. Defective RVOTs require open heart surgery called RVOT reconstruction, which usually involves replacing the pulmonary valve.
About cardiovascular recovery
The currently available valve replacement options are either short-lived or may require long-term medication.6,7 Xeltis devices are evolving into living heart valves in the body by colonization with the patient’s own tissue to overcome the limitation of existing options. This therapeutic process is known as endogenous tissue repair, or ETR. With ETR, the Xeltis heart valve functions like a “home” for the patient’s tissue, which develops as part of natural healing. The new tissue makes the device a new, living and fully functional heart valve. As the new living valve takes over the functionality, the original synthetic structure is gradually absorbed into the body.
Via the Xplore2 / Pivotal trial version
Xplore2 / Pivotal is an FDA-cleared prospective, non-randomized, open clinical study of Xeltis’ restorative pulmonary heart valve in patients in need of right ventricular outflow tract (RVOT) reconstruction. The study will enroll up to 50 patients, ages 2-22, at up to 15 centers in the United States, Europe, and Asia, including currently: Cincinnati Children’s Hospital, Cincinnati, OH; University of Texas Southwestern Medical Center, Dallas (TX); Colorado Children’s Hospital, Aurora (CO); Los Angeles Children’s Hospital (CA); University Children’s Hospital, Krakow (Poland); National Cardiological Hospital Sofia (Bulgaria); National Heart Institute, Kuala Lumpur (Malaysia). More information: www.xplore2MD.com; www.clinicaltrials.gov ID: NCT03022708.
About Xeltis
As a clinical stage medical device company, Xeltis has developed the most advanced polymer-based restorative devices for cardiovascular treatment. Xeltis’ restorative devices include heart valves and small diameter blood vessels for coronary artery bypass surgery (CABG) and hemodialysis vascular access.
Xeltis was created through the merger of two Dutch-Swiss university spin-offs and is currently active in the Netherlands and the USA. Xeltis investors include the Kurma Partners, LSP, VI Partners and Ysios Capital venture capital funds, as well as a number of private investors.
CAUTION: Xeltis technology is a test device and is NOT approved for sale.
1Morales DL, Herrington C, Bacha EA, Morell VO, Prodán Z, Mroczek T, Sivalingam S, Cox M, Bennink G and Asch FM (2021) A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials. Front. Cardiovascular. Med. 7: 583360. doi: 10.3389 / fcvm.2020.583360
2 Xeltis data in file
3 Hoffman JL, Kaplan S. The incidence of congenital heart defects. J Am Coll. Cardiool. 2002; 39 (12): 1890-1900.
4 Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A. Prevalence of congenital heart defects in Atlanta, 1998-2005. J Pediatr. 2008; 153: 807-13.
5 Center for Disease Control and Prevention. Congenital heart disease data and statistics. Retrieved online on June 24th, 2021 at https://www.cdc.gov/ncbddd/heartdefects/data.html#References
6 BreymannT. et al. European multicenter Contegra study: 7-year results after 165 implantations of jugular vein grafts with valves in cattle. Thorac Cardiov Surg 2009; 57: 257-269
7 Rüffer A. et al. Medium-term experience with the Hancock Dacron conduit with venous valves for reconstruction of the right ventricular outflow tract. Eur J Cardiothorac Surg. 2012 Dec; 42 (6)
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