MiMedx Group, an integrated developer, manufacturer and marketer of patent protected orthopedic biomaterial-based products, has received notification by the FDA that its proprietary device, HydroFix Vaso Shield, has received 510(k) clearance for additional thicknesses and sizes.
Reportedly, in April 2009, the FDA had cleared HydroFix Vaso Shield for use as a cover for vessels following anterior vertebral surgeries. The Vaso Shield is a permanent and transparent hydrogel product protected by multiple patents and patent applications, as well as a proprietary manufacturing process.
MiMedx Group said that during an anterior spinal implant procedure, the physician places the Vaso Shield between the spinal implant site and the vessels and then sutures it to the perivertebral, non-vascular soft tissue to secure the implant. The device is designed to protect the vessels in subsequent anterior revision surgeries.
MiMedx has recently completed a Level 2 Comprehensive FDA Inspection of its Marietta, Georgia facility and was pleased with the results. The company will also expand its European product offering of HydroFix Spine Shield to offer similar configurations as the HydroFix Vaso Shield.
Parker Petit, chairman and chief executive officer of MiMedx, said: “In the initial 510(k) FDA submission, the device was presented with a thickness of 1.0mm. During the ‘soft launch’ of HydroFix Vaso Shield, the physician receptivity was excellent and we received valuable feedback that they wanted to utilize the device in varying thicknesses.
“In response to their feedback, we submitted a subsequent 510(k) for the device. The FDA has now cleared HydroFix Vaso Shield for multiple thicknesses ranging from 0.4mm to 1.0mm and multiple sizes.”
William Taylor, president and chief operating officer of MiMedx, said: “It is a very difficult job to establish a strong, compliant quality system in a start-up organization and it is even more difficult to ensure compliance with that system. We are very proud of our team. The results of the audit prove that our team has done a great job, and demonstrate management’s commitment to producing high quality products that meet or exceed applicable regulatory requirements.”