Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.
To date, no cardiovascular model has been able to shed light on how and why cardiac congenital disorders start in the human embryo. Researchers from the Institute of Molecular Biotechnology (IMBA) in Vienna have been able to recapitulate cardiogenesis in multi-chamber cardioids, sort of interacting heart chambers intended to dissect how genetic and environmental factors impact human heart development.
Heartpoint Global Inc. will begin human trials of its Intellistent device shortly and expects to make submission to the U.S. FDA in 2024, Seth Bogner, its chairman and CEO told BioWorld in an interview on the sidelines of the EuroPCR conference in Paris. Intellistent is a multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. It is a minimally invasive device that will meet an unmet need in pulmonary artery hypertension caused by congenital heart disease, said Bogner.
Xeltis BV has completed a €32 million (US$34 million) series D2 round that will propel the clinical development of its electrospun polymer implants across several indications. The fully synthetic implants promise the best of both worlds, with the mechanical strength required to be fully functional from day one, and bioresorbable properties that cause gradual degradation as endogenous tissue regenerates to form a natural replacement.
Researchers from Monash University in Melbourne have developed a method for determining which genes are "in play" in causing cardiac abnormalities, and the technique not only confirmed well-known congenital heart disease genes, but also discovered 35 new genes not previously suspected in the disease.
The FDA approved the world's first non-surgical heart valve to treat severe pulmonary valve regurgitation, which often affects individuals with congenital heart disease. Medtronic plc’s Harmony transcatheter pulmonary valve system (TPV) improves blood flow to the lungs without open-heart surgery. The device could extend the time before an individual born with heart disease needs open-heart surgery and the total number of such surgeries they have to endure over their lifetime.
Two teams of researchers have developed miniature models of the human heart that beat and function like the full-size organ. The team from Michigan State University (MSU) and Washington University in St. Louis developed a human heart organoid (hHO) that recapitulates embryonic heart development, providing an unmatched view into congenital heart defects. The organoid created by the researchers at the Medical University of South Carolina (MUSC) and Clemson University mimics the tissue dysfunction that occurs following a heart attack.
