Devon Medical Products Receives SFDA Clearance To Market U.S.-Manufactured ViewSite™ Brain Access System (VBAS) In People’s Republic Of China

Devon Medical Products, a global medical device designer, manufacturer, and distributor, announced it has received clearance to market the ViewSite™ Brain Access System (VBAS) neurosurgery device in the People’s Republic of China from the State Food & Drug Administration (SFDA), the country’s governing medical device body.

VBAS is made in the United States by Vycor Medical, Inc., a medical device company specializing in products for neurosurgery. Devon Medical Products is Vycor’s distributor in China.

Devon Medical Products also announced PKUcare BeiYi Pharmaceutical Co. Ltd., a subsidiary of Peking University International Healthcare Group, as its co-distributor of VBAS in China.

“This regulatory approval has significant implications for surgeons and patients who will be able to benefit from the VBAS device in China as they have in the United States,” says Dr. John A. Bennett, president and CEO of Devon Medical Products. “Our goal is to help sell U.S.-made medical devices to the rest of the world to both support the U.S. economy but also improve quality of care where needed in other countries. We are excited to continue our strong relationship with Vycor Medical, and are proud to be working with a healthcare industry giant like PKU BeiYi Pharmaceutical Co. Ltd. to bring this innovative device to Asia.”

VBAS is a brain access and retraction device that allows higher precision for surgeons in reaching target areas in the brain, such as tumors and hemorrhages, in a minimally invasive manner. VBAS helps surgeons see surrounding tissue better during surgery and allows them to reposition the retractor fewer times during surgery. The result is higher accuracy, less tissue trauma, and potentially faster recovery for patients.

“VBAS has received outstanding reviews from surgeons in the United States where it continues to gain traction with hospitals and neurosurgeons,” says Kenneth T. Coviello, CEO of Vycor Medical. “We are excited to begin working with healthcare professionals in China and look forward to the expansion of VBAS in Asia where we believe there is tremendous potential.”