WALTHAM, Mass.--()--Correx, Inc. today announced that patients requiring treatment of critical aortic stenosis have a new, less invasive option that is gaining worldwide traction. This new treatment will be prominently featured at the 26th Annual European Association for Cardio-Thoracic Surgery (EACTS) Conference in Barcelona, Spain, on Saturday October 27th. Cardiac surgeons Drs. Steffen Hofmann and Michael Billion, of the Schüchtermann Klinik in Bad Rothenfelde, Germany, using Correx’s approved surgical system, will perform off-pump Aortic Valve Bypass (AVB) surgery on a patient with critical aortic stenosis. The Correx Kit is CE Marked for treating all risk categories of symptomatic aortic stenosis.1
“He is doing very well with a peak gradient of 18 mmHg (normal function). It is great to have access to the Correx AVB Kit to treat aortic stenosis effectively.”
Otherwise known as Correx Aortic Valve Bypass or CAVB®, the procedure will occur at the Herzzentrum Leipzig in Leipzig, Germany while conference attendees view the procedure in real time through live transmission. Dr. Oliver Reuthebuch of Universitätsspital Basel in Basel, Switzerland, will provide live commentary to the conference as the case proceeds in Leipzig.
“Our experience with Correx AVB in nine clinical cases to date confirms its ease of use and ability to relieve left ventricular outflow tract obstruction of aortic stenosis,” said Dr. Reuthebuch. “It is an important new possibility to treat high risk patients with severe aortic stenosis avoiding the heart lung machine by operating on the beating heart nearly without risk for cerebral infarction (stroke) or need for pacemaker implantation.”
The first patient to receive CAVB® is nearly two years from his surgery.2 He had presented with shortness-of-breath, light-headedness and chest pain. A history of prior stroke made other procedures highly risky. He underwent CAVB® without complications and left the hospital for home 5 days later. “I haven’t felt this good in ten years,” said this now 77 year-old male. “I can travel, and I exercise as much as I want. I have a wonderful quality of life and am so grateful.”
Dr. Bob Kiaii, who performed the first patient’s CAVB® surgery at London Health Sciences Centre in London, Ontario, Canada, remarked, “He is doing very well with a peak gradient of 18 mmHg (normal function). It is great to have access to the Correx AVB Kit to treat aortic stenosis effectively.”
Correx, Inc., a US-based med-tech company, developed CAVB® to provide cardiac surgeons a new treatment option for their patients with aortic stenosis. “We are honored to contribute our Correx Kit to the performance of a CAVB® case by a distinguished group of surgeons,” said J. Alan Crunkleton, PhD, MD, Correx’s CEO. “We are grateful to the EACTS selection committee for inviting CAVB® to be profiled in front of this year’s conference attendees. We believe that the CAVB® system addresses the treatment needs of a growing number of patients with aortic stenosis. We look forward to supporting this trend as clinical data mounts and surgeons gain more experience with the procedure.”
ABOUT AORTIC STENOSIS AND AORTIC VALVE BYPASS
Aortic stenosis, or narrowing and calcification of the valve leading from the heart to the rest of the body, can result in diminished blood outflow from the heart. This leads to shortness-of-breath, light-headedness and eventually heart failure as the heart pumps harder and harder to overcome the obstruction.
Aortic Valve Bypass (AVB) employs a bypass technique to treat aortic stenosis. With AVB, surgeons relieve the obstruction to blood flow at the narrowed aortic valve by inserting a conduit containing a valve between the apex of the heart and the descending aorta. Post surgery, the diseased aortic valve continues to function in concert with the bioprosthetic valve in the bypass implant.
Without the Correx system, however, AVB is a technically challenging procedure. As a result, AVB has not been widely adopted despite literature spanning more than 30 years reporting excellent clinical results for high risk patients. Included in the data are reports of many patients who have returned to normal daily function and lived for many years or even decades post surgery.
ABOUT CORREX AORTIC VALVE BYPASS (CAVB®)
Correx, Inc. has commercialized a complete system that dramatically facilitates the AVB procedure. With the Correx system, surgeons can now perform AVB off-pump (without the heart lung bypass machine), on a beating heart through a small incision on the left side. A trained surgeon can complete the Correx Aortic Valve Bypass (CAVB®) procedure in only 2 hours. Initial results confirm that CAVB® avoids or reduces conventional treatment-related complications.
Correx believes that its CAVB® system transforms AVB from a technically difficult, niche procedure to a highly reproducible, durable solution for critical aortic stenosis patients in all risk categories. The CAVB® system includes a proprietary insertion device that enables surgeons to seamlessly and consistently insert the implant into a beating heart with minimal blood loss. The bioprosthetic valve in the CAVB® system has been used for more than a decade in conventional surgery with proven durability. The tube housing the valve is a standard graft used in surgeries to replace sections of aorta.
CAVB® employs the “No Touch™ Approach”, providing a solution to the blood flow obstruction without manipulating the diseased aortic valve. As a result, the incidence of stroke with CAVB® is rare. The “No Touch™ Approach” also avoids procedure-related permanent pacemaker implantation, which can be required with other treatments when the heart’s conduction system is inadvertently injured by manipulation of the area around the aortic valve.
CE Mark Indications: The Correx AVB Kit is intended to relieve left ventricular outflow tract obstruction in patients with critical aortic stenosis. Contraindications: The Correx AVB Kit is not intended for patients with severe aortic insufficiency.
For further information, please visit www.correxinc.com.
1 The Correx AVB-18MM Kit is not for sale in the United States.
2 Adams C., Guo LR et al. Automated Coring and Apical Connector Insertion Device for Aortic Valve Bypass Surgery. Ann Thorac Surg 2012; 93: 290-293.