Boca Raton, Florida, USA (PRWEB)
September 19, 2017
Ascyrus Medical LLC. today announced the results of the first implants of the ADS Hybrid Graft in a clinical study for the treatment of acute Stanford Type A Dissections. To date three patients have been treated with the ADS system as part of a clinical investigation called the DARTS Trial. The procedures were performed by Michael Moon, MD, Department of Cardiothoracic Surgery at the University of Alberta, Edmonton, Canada. All patients were successfully treated with the ADS and a remarkable healing of the aorta and the great vessels has been observed on follow up imaging and CT scans. The implantation of the ADS system was very intuitive and the positioning and deployment of the device added only 2-5 minutes to the planned procedure. The longest completed follow-up is 6 months in duration.
Current treatment options for patients suffering from acute type A dissection are limited. Today’s standard of care involves open heart surgery and replacement of the ascending aorta with a polyester graft. Following successful emergency surgery 75-80% of the patients will continue to battle a chronically persistent false lumen (PFL) that in 50% of cases leads to additional aortic procedures over the first decade after diagnosis with an equally high mortality rate in the long term. Alternative options to date for the treatment of the PFL, have either been more invasive and risky in the face of an acutely ill patient with a potential for serious complications, or options with unreliable and limited efficacy. The ADS is a device specifically designed for the treatment of acute type A dissections to effectively treat the PFL in order to decrease the long-term complications and procedures associated with the disease.
“The management of patients with acute type A dissections is extremely challenging, and surgical options for these patients focus primarily on the acute setting and to saving the patients’ life. The acute life-threatening condition is treated emergently and the disease is converted to a chronic illness where we over time manage the complications that ensue. The ADS has the ability to shift this management paradigm and offer a tool to actually heal the aorta beyond todays standard of care repair” said Michel Moon, MD, Cardiac Surgeon at the University of Alberta in Edmonton and the…