July 1, 2020
IDE Approved for Trial of Carag’s Transcatheter Bioresorbable Septal Occluder
July 1, 2020—Carag AG, a Switzerland-based medical device company, announced it has received FDA investigational device exemption approval for the Carag bioresorbable septal occluder (CBSO), the company’s transcatheter septal occluder with a bioresorbable, metal-free framework.
The prospective, multicenter, clinical trial is designed to enroll up to 250 patients in the United States in a staged study approach to evaluate the safety and efficacy of the CBSO in patients with clinically significant atrial septal defect (ASD). Carag expects trial enrollment to begin in late 2020, and it will be the largest clinical trial for the company to date.
Larry Latson, MD, and Saibal Kar, MD, are the Coprincipal Investigators for the United States trial. Dr. Latson is from Joe DiMaggio Children’s Hospital in Hollywood, Florida. Dr. Kar is from Los Robles Medical Center in Thousand Oaks, California.
“Based on the data seen so far, we are very hopeful that a metal-free bioresorbable framework has the potential to reduce the risk of late complications for patients,” commented Dr. Latson in Carag’s press release. “With heart procedures requiring septal crossing on the rise, a framework that dissolves when no longer needed would improve future treatment options. Both benefits would represent major advancements in ASD treatment.”
According to the company, results from its first-in-human trial conducted in Germany demonstrated that the CBSO is easy to use, with excellent closure results at procedure and at 2-year follow-up, with no serious device-related complications reported. The CBSO gained European CE Mark approval in 2017 and is currently being implanted as part of a postmarket registry in selected centers in Germany and Switzerland.