MEDICREA’s PASS MIS: FDA Approval and First Surgery in the US

LYON, France, Feb 07, 2012 (BUSINESS WIRE) — The MEDICREA group, a medical company specialized in the development of innovative surgical technologies for the treatment of spinal pathologies, today announced the approval by the FDA of the PASS MIS system and the first PASS MIS surgery performed in the U.S. by Dr. Victor Hsu (Doylestown Hospital, Pennsylvania. USA).
Dr. Hsu commented after his first surgery: “I found the PASS MIS system to be very intuitive and efficient to use. I believe this system allowed me to reduce my instrumentation time by 50% due to the limited instruments needed and tactile rod delivery method.”
The PASS MIS system offers a simplistic technique to perform both short and multi level complex constructs through a percutaneous approach. The PASS MIS system builds off the company’s core PASS technology – employing a polyaxial posted screw and top loading connector design – allowing all surgeons to discover the benefit of MIS surgery without extensive training.
Dr Labbe an experienced trauma surgeon (Nouvelle Caledonie, France) further explains the unique possibilities with the PASS MIS system in trauma indications : “Where most surgeons traditionally combine a kyphoplasty reduction (first) and screw and rod fixation (second), the PASS MIS system allows this sequence to be reversed. This enables us to rely on the power of the reduction of the screws and rod to better reduce the patient’s spine in an anatomical position. Once this is achieved the lateral or medial rod placement leaves free access to the fractured vertebrae pedicle through which the cement will be inserted. The PASS MIS hence becomes the ideal complement to the kyphoplasty technique.”
For the treatment of vertebral fractures, percutaneous screw placement is fast becoming the technique of choice among the spinal community. The PASS MIS system should consequently outperform existing products for those indications due to the unique top loading — offset rod placement characteristics further partnered by its specialized reduction maneuvers. Denys Sournac, President and CEO, concludes: “With the PASS MIS accessing the US market, our subsidiary Medicrea USA Corp. now has a technology platform that can address most of the degenerative indications of the spine through a posterior minimally invasive approach in thoracic and lumbar levels. The PASS MIS system is currently in a limited release phase throughout the U.S., Europe and Asia with key opinion leaders in this area of surgery and is expected to move to a worldwide launch by Q4 2012.”