Israeli company soon to begin trial on stroke-risk reduction device
The company completed its first pre-clinical chronic procedure, alongside IMMR, one of the world's leading pre-clinical laboratories.
By JERUSALEM POST STAFFVirtual image of human heart (photo credit: ING IMAGE/ASAP)
Append Medical, an Israeli medical start-up based in Or Yehuda, has been given special permission, despite COVID-19 restrictions, to present their promising technology to help atrial fibrillation (AF) patients.MEDX Xelerator, allowing Append Medical to showcase its technology amid the pandemic, is a medical device and medtech incubator that was created as a joint venture of Boston Scientific, MEDX Ventures and Sheba Medical Center."The Appligator," as the device is called, is designed to seal the Left Atrial Appendage (LAA) without an implant. It does this using a patented tissue manipulation procedure, which is meant to reduce the risk of stroke in patients with non-valvular atrial fibrillation, a condition connected to 20% of the 33 million annual cases of stroke worldwide.The device prevents blood clot leakage with a minimally invasive transseptal intervention, leaving no implant behind. This is made to minimize device-related thromboembolism risk by leaving only a suture.The company completed its first pre-clinical chronic procedure alongside IMMR, one of the world's leading pre-clinical laboratories, which paves the way for the beginning of the first human trials for the technology.“These first procedures provide an important validation for our approach, which is intended to significantly simplify the goal of sealing the LAA and preventing stroke in AF patients without leaving any implant in the heart,” said Zachi Berger, PhD, Founder and CEO of Append Medical."Both animals are doing fine so far, and the post-procedure images are spectacular. Congratulations to the Append team on this achievement,” said Dr. Nicolas Borenstein, DVM, PhD, IMMR's Scientific and Technical Director.IMMR is a Paris-based company which helps design and conduct pre-clinical studies in large models. It also provides FDA-inspected facilities for completing studies.
