News | Heart Valve Technology | October 04, 2016

First Bioresorbable Heart Valves Implanted to Enable Cardiovascular Restoration

Three European children implanted with Xeltis bioabsorbable pulmonary heart valve in feasibility study

Xeltis bioabsorbable pulmonary heart valve, Xplore-I clinical feasibility study, first pediatric implants, EACTS 2016

October 4, 2016 — Xeltis 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 the 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 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).

VIDEO: How the Xeltis Bioresorbable Pulmonary Valve Works

“The Xplore-I patients are doing well and have been discharged from hospital,” said 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.

Prodan presented trial details at the 30th Annual Meeting of the European Association of Cardio-Thoracic Surgery (EACTS), Oct. 1-5 in Barcelona, Spain.

"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.

The Xeltis bioabsorbable heart valve employs a technique known as endogenous tissue restoration (ETR). ETR is a novel therapeutic approach in cardiovascular regenerative medicine enabling the restoration within the body of complex cardiac parts with patient’s own tissue. The porous structure of a Xeltis bioabsorbable heart valve enables cardiovascular restoration by harnessing the body’s natural healing process to pervade it with new healthy tissue once implanted. As a new healthy heart valve or blood vessel made of patient’s own tissue forms around the structure of the implant and takes over functionality, the implanted valve gets absorbed in the body.

For more information: www.xeltis.com

Related Content

Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...
News | Cath Lab | December 18, 2019
December 18, 2019 — Cook Medical initiated a recall of its CrossCath Support Catheters in November, which the U.S.