MiMedx Group, Inc., an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification by the FDA that the Company’s proprietary device, HydroFixT Vaso Shield, has received 510(k) clearance for additional thicknesses and sizes.
In April 2009, the FDA cleared HydroFixT 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. 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.
Parker H. “Pete” Petit, MiMedx Chairman and Chief Executive Officer, said, “In the initial 510(k) FDA submission, the device was presented with a thickness of 1.0mm. During the “soft launch” of HydroFixT 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 HydroFixT Vaso Shield for multiple thicknesses ranging from 0.4mm to 1.0mm and multiple sizes.” “We are excited about the opportunity to expand the marketing of our product with the multiple thickness clearance and further serve the needs and surgical preferences of the physicians that utilize our devices,” added Petit.
The Company will also expand its European product offering of HydroFixT Spine Shield to offer similar configurations as the HydroFixT Vaso Shield.
MiMedx also reported that it has recently completed a Level 2 Comprehensive FDA Inspection of its Marietta, Georgia facility and was pleased with the results. William C. Taylor, MiMedx President and Chief Operating Officer, commented, “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.”