News | Heart Valve Technology | September 09, 2016

Bioresorbable Pulmonary Valve Replacement May Enable Cardiovascular Regeneration

New six-month preclinical data showed that Xeltis bioabsorbable aortic conduct enabled endogenous tissue regeneration in the systemic circulation

Xeltis bioabsorbable aortic conduit, endogenous tissue restoration, ETR, preclinical data, ISACB 2016

September 9, 2016 — Six-month preclinical data from trials of a Xeltis bioabsorbable aortic conduit were presented at the 2016 scientific meeting of the International Society for Applied Cardiovascular Biology (ISACB). The data was presented by Prof. Frederick Schoen, M.D., Ph.D., senior pathologist and executive vice chairman, Department of Pathology at Brigham and Women’s Hospital, and professor of pathology and health sciences and technology, Harvard Medical School.

The data showed that a Xeltis bioabsorbable aortic conduit enabled endogenous tissue restoration (ETR) in the systemic circulation, the part of the cardiovascular system flowing via the aorta throughout the body. Systemic circulation is characterized by higher blood pressure than pulmonary circulation, a loop through the heart and lungs. Xeltis bioabsorbable cardiovascular technology has already been proven to effectively enable ETR in pulmonary circulation.

Watch a VIDEO animation of how the Xeltis valve is supposed to work

Clinical data presented at the American Association for Thoracic Surgery in May 2016 showed anatomical and functional stability of Xeltis devices in a feasibility study of five pediatric patients and no adverse events at one-year follow-up. Indeed, two-year follow-up data are expected to be ready soon and presented at a major scientific meeting.

According to the company, Xeltis technology is the first-ever cardiovascular regenerative medicine platform based solely on a bioabsorble device. By pervading the porous Xeltis matrix, new tissue forms around and inside it and rebuilds a new heart valve or blood vessel. Xeltis devices are designed to absorb over time, leaving patients with a new, healthy, functioning heart valve or blood vessel. Current valves are plagued with complications: the potential for rejection, calcification and chronic infection.

Preclinical data was initially presented by Schoen at the 10th World Biomaterials Congress in June 2016 validating the potential of Xeltis devices to “guide the restoration of a patient’s natural tissue into a functional living vascular replacement.”  

The Xeltis platform is the first to apply the principles of supramolecular chemistry and the properties of bioabsorbable polymers to enable cardiovascular regenerative medicine via implanted medical devices. The ETR process enabled by Xeltis devices does not require any in vitro tissue engineering, stem cells or other biological agents.

The platform is protected by a portfolio of 20+ international patent families, including Xeltis’ supramolecular polymer platform and its electrospinning methodology for manufacturing the devices. Electrospinning is a fiber production method that uses electric force to draw solid, charged threads from polymer solutions or polymer melts up to fiber diameters a fraction of the diameter of a hair.
Jean-Marie Lehn, Ph.D., co-winner of 1987 Nobel Prize in Chemistry, said, “Supramolecular chemistry enables Xeltis technology by providing unique biochemical and biomechanical properties, delivering solutions to issues faced by traditional materials over the course of decades.”

Schoen said, “I am impressed by the Xeltis preclinical results to date that have advanced our understanding of host/biomaterial interactions and show potential for an innovative approach that could improve the care of patients with cardiovascular disease.”

Martin B. Leon, M.D., director, Center for Interventional Vascular Therapy, Columbia University Medical Center/New York-Presbyterian Hospital, said, “I am excited by the potential of the Xeltis technology for the replacement of heart valves, bringing significant benefits not only to the procedure and valve designs but also to clinical outcomes for patients.”

Lehn, Schoen and Leon are scientific advisors to Xeltis. The Xeltis technology is investigational and not available for sale.

For more information:

Related Content

Hypertension Found in Children Exposed to Flower Pesticides
News | Congenital Heart | June 03, 2019
Researchers at University of California San Diego School of Medicine found higher blood pressure and pesticide...
Edwards Recalls Miller and Fogarty Balloon Dilation Atrioseptostomy Catheters
News | Congenital Heart | April 29, 2019
Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy...
New Pediatric Blood Pressure Guidelines Improve Premature Heart Disease Identification
News | Congenital Heart | April 22, 2019
New guidelines that classified more children as having elevated blood pressure  are better at predicting which kids are...
Better Options Needed for Children at Higher Risk of Premature Heart Disease
News | Congenital Heart | February 28, 2019
Obesity and severe obesity in childhood and adolescence have been added to the list of conditions that put children and...
Climate Change May Increase Congenital Heart Defects
News | Congenital Heart | January 30, 2019
Rising temperatures stemming from global climate change may increase the number of infants born with congenital heart...
Videos | Congenital Heart | November 01, 2018
Example of GE Healthcare’s FetalHQ software for the ultrasound imaging of fetal hearts.
Cardiac Ultrasound Software Streamlines Fetal Heart Exams
Feature | Congenital Heart | October 30, 2018
A new tool called fetalHQ on GE Healthcare’s Voluson ultrasound systems is the first tool to simultaneously examine the...
St. Louis Children's and Washington University Heart Center Perform Rare Infant Heart-Lung Transplant

Image courtesy of St. Louis Children's and Washington University Heart Center

News | Congenital Heart | September 25, 2018
Five-month-old Jack Palmer is home with his family in Kansas City after undergoing an extremely rare heart-lung...
New Research Explores Role of Gene Mutation in Congenital Heart Defects
News | Congenital Heart | June 18, 2018
June 18, 2018 — Heart defects are the most common type of birth defect, and can be caused by mutations in the gene CH
Global Study Examines Therapy for Patients with Single-Ventricle Cardiac Defect

Image courtesy of Hayek Medical

News | Congenital Heart | May 02, 2018
Select adult patients born with a single functioning ventricle, and who have undergone a surgical operation called the...
Overlay Init