Panther Orthopedics Inc., is reporting exceptional mid-term clinical outcomes of its PUMA System. The PUMA System is the first and only U.S. Food and Drug Aministration-cleared superelastic syndesmosis device featuring a spring-like design that provides initial and continuous compression without the need to over-tension.
 
“I consider the PUMA System to be a game changer. Its novel technology allows me to provide the best care available to my patients. Its biomechanics marry perfectly with biology, stability, fixation and strength. I have used it for almost two years in a wide range of patients, from athletes to high-energy trauma, and have seen excellent outcomes with no complications,” said Kent Ellington, M.D., a foot and ankle surgeon with OrthoCarolina in Charlotte, N.C.
 
“The PUMA System is a nitinol-based fixation device for the ankle syndesmosis which provides stabilization without over-compression or loosening with cyclical loading. Nitinol has a proven safety record in foot and ankle surgical repair and reconstruction implants. Bringing nitinol into use for ankle syndesmotic injuries with the PUMA System is a novel innovation with significant advantages over existing screw or endobutton type fixation devices. The PUMA System provides significant syndesmotic stabilization while also allowing for more normal ankle biomechanics. The biomechanical and clinical advantages of this implant have led to improved patient outcomes after these ankle injuries,” said Edward Tang, M.D., a sports medicine and foot and ankle surgeon at Contra Costa Regional Medical Center in Martinez, Calif.
 
The PUMA System is the first and only superelastic fixation device for the syndesmosis market that provides continuous compression without creep during the healing phase. Therefore, there is no need for over-compression of the distal tibiofibular syndesmosis which can lead to crushing of the microvasculature, malreduction and a stiff joint. In this initial commercialization, over 50 patients were followed for procedural safety and healing response via postoperative radiographic and clinical evaluations for up to 22 months.
 
“We are excited about our clinical results demonstrating excellent joint healing and early return to mobilization and physical activity. We confirmed satisfactory radiographic syndesmosis healing with reduction in the ankle mortise in 100% of these patients and there was no evidence of lysis, device migration or syndesmotic widening. Additionally, there were no infections, soft tissue complications or devices requiring removal or revision surgeries,” said Kathy Stecco, M.D., CEO and co-founder of Panther Orthopedics.