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Cayenne Medical AperFix(R) System Shows Successful Outcomes For PCL Reconstruction
Clinical Study Reports Restoration of Knee Stability and Range of Motion at Six-Months
SCOTTSDALE, Ariz., April 8 /PRNewswire/ — Cayenne Medical, Inc. (Cayenne), a privatelyheld sports medicine device company, announced that a new independent clinical studypublished in the February 2010 issue of Orthopedics reports Cayenne’s AperFix® Systemprovides a safe, efficient and secure means of arthroscopic reconstruction of the posteriorcruciate ligament (PCL) due to traumatic injury.
The AperFix System is a femoral and tibial fixation device originally designed for soft tissueanterior cruciate ligament (ACL) reconstruction. AperFix is proven to restore native kneekinematics through a simple, single incision, “all-inside” technique that allows the implant to beinserted transtibially, or anteromedially, through a single-tunnel, and eliminates the need to drillthrough the femoral cortex.
The study, titled “Arthroscopic PCL Reconstruction with a Novel All-Inside Femoral FixationDevice: A Single-Incision Technique,” is authored by John W. Uribe, M.D. and Luis Vargas,M.D. of UHZ Sports Medicine Institute, Coral Gables, FL, and Brian M. Leo, M.D. of ClevelandClinic Florida, Weston, FL.
“PCL reconstruction with the AperFix System is designed to alleviate the challenges somesurgeons may experience with conventional BTB (bone-tendon-bone) allografts or soft tissuegrafts utilizing cortical fixation techniques,” said James W. Hart, President and CEO of CayenneMedical. “This study not only highlights the flexibility of the system as a solution for multipleligament reconstructions, it also shows the novel procedure provides superior fixation and kneestability for patients and ease-of-use for surgeons due to aperture fixation.”
In the study, six active PCL injury patients successfully underwent PCL reconstruction surgeryusing the AperFix System. At six months, all patients achieved restored knee stability and full,symmetric range of motion, allowing them to return to their previous level of activity. Fullrecovery following PCL reconstruction surgery typically requires six to 12 months.(i)Study authors concluded that the AperFix System’s single-incision all-inside femoral fixationtechnique efficiently performs arthroscopic soft tissue PCL reconstruction. Authors cited benefitscompared to traditional methods, which include reduced bone and soft tissue injury, eliminatedneed for patient repositioning during surgery and a simplified passage of the allograft through theposterior aspect of the tibia.
The AperFix System originally received market clearance from the U.S. Food and DrugAdministration (FDA) for soft tissue ACL reconstruction in 2007. In March 2009, AperFixFemoral and Tibial Implants received 510K clearance for extended indications, including a widevariety of tenodesis procedures such as PCL, MCL, LCL and MPFL reconstruction. AperFiximplants are made of polyetheretherketone (PEEK™) and provide surgeons with aperturefixation, superior pullout strength and active, circumferential tendon compression.
About the Study
The study examined clinical outcomes of six active PCL reconstruction patients (mean age = 36years) who underwent soft tissue PCL reconstruction using Cayenne’s AperFix System singleincisionall-inside approach, with an average length of time from injury to surgical reconstructionof 19.5 months. The indications for surgery were an acute PCL rupture diagnosed clinically andby magnetic resonance imaging (MRI). All arthroscopic procedures were performed by Dr. JohnW. Uribe of UHZ Sports Medicine Institute, Coral Gables, FL.
Patients were evaluated at six months (6 patients) and one year (3 patients) postoperatively. Atsix months all patients were pleased with their surgical outcome, had returned to their pre-injurylevel of activity and achieved full, symmetric range of motion. There were no complicationsresulting from the procedure.
About Cayenne Medical, Inc.:
Based in Scottsdale, Arizona, Cayenne Medical is a privately held medical device companydefining new technology for the soft tissue reconstruction segment of the sports medicinemarket. The company was founded in 2005 and is focused on leading the transformation oftraditional ACL, PCL, and meniscal repair procedures, by applying advanced technology throughminimally invasive techniques. For more information, go to www.cayennemedical.com.(i) American Orthopaedic Society for Sports Medicine via http://orthoinfo.aaos.org/topic.cfm?topic=a00420Contacts:Tim Nash Scott LermanCayenne Medical The Ruth Group(480) 502-3661 (646) firstname.lastname@example.org email@example.com