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 Canadian National Principal Investigator of the study. “Through the DARTS Trial, we are hoping to gather evidence to support the use of this device in a patient population that today has limited options for a durable and effective treatment approach to their emergency dissection repair.”
Deployed using an intuitive delivery mechanism that takes a very short time, the device is designed to provide cardiothoracic surgeons the ability to treat the PFL and the dissection in the arch and descending aorta during the time of the emergency repair of the dissection. The ADS Hybrid Graft combined with the standard of care ascending aortic replacement enforces an extended repair of the aorta with the goal to reduce the long-term healing of the dissection, an option that has not been available to patients and surgeons to date.
“We are excited to participate in the DARTS Trial. The ADS has offered our sickest patients a new alternative for a more effective treatment of the dissection and the results have been very positive to date. All procedures have gone very well without any technical difficulties. The ADS was very intuitive to use and the rapid deployment mechanism allowed us to complete the dissection repair without any significant time added to the standard of care procedure.” said Dr. Moon.
The Ascyrus Medical Team is both proud and excited about the remarkable and exciting results observed in the DARTS Trial.
About Ascyrus Medical LLC.
Ascyrus Medical LLC. is a privately owned medical device company that has developed proprietary technology designed to heal aortic dissections involving the ascending aorta and aortic arch (Stanford type A/ DeBakey I classification). Ascyrus Medical was founded in January 2015, recruiting a group of world renowned engineers and physician experts all with a focused and unique expertise in aortic diseases, with the goal to develop a unique stent for treatment of acute type A ( a.k.a DeBakey I) aortic dissections. The ADS technology will serve to save and improve the lives of patients by reducing the immediate and long-term impact of the disease.