Here’s a roundup of recent clinical trial and scientific study news:
- Medtronic touts CoreValve study
Medtronic Inc. (NYSE:MDT) issued a statement on results from an independent study published online in the journal Circulation, which confirmed both early and sustained clinical benefits for patients receiving the Medtronic CoreValve System for the treatment of aortic valve disease. The article, “Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis,” discusses the largest CoreValve clinical study to date, with 663 consecutive aortic stenosis patients (mean age of 81 years) treated at 14 Italian centers beginning immediately after device commercialization in 2007. The article shows that patients receiving CoreValve have high rates of procedural success (98 percent), low rates of adverse events (2.1 percent) and substantial improvements of cardiac function. The CoreValve System is a minimally invasive, non-surgical treatment option for patients with requiring aortic valve replacement who are considered at high risk for surgery; it is delivered via transcatheter aortic valve implantation (TAVI) rather than open-heart surgery.
- Zimmer’s Longevity highly crosslinked polyethylene demonstrates long-term clinical success
Zimmer Holdings Inc. (NYSE:ZMH) announced that results of an independent study presented at the 2011 American Academy of Orthopaedic Surgeons (AAOS) annual meeting demonstrated long-term clinical success for Longevity highly crosslinked polyethylene. The study, by a team from the Massachusetts General Hospital, included radiographic analysis from a 299 patient cohort receiving primary total hip arthroplasties using Zimmer’s Durasul or Longevity highly crosslinked polyethylene liners. It is the largest series and longest follow-up period to date for highly crosslinked polyethylene material. Radiographic results presented in the study indicate very low wear in vivo with no signs of change over time and no signs of periprosthetic osteolysis in the patient cohort. Zimmer’s Longevity highly crosslinked polyethylene is formulated specifically to resist wear under the conditions found in hips and represents a significant scientific advancement in wear reduction.
- Clinical advantages of Trabecular Metal technology demonstrated in new studies
Zimmer also announced that results from two clinical studies reinforce the clinical advantages of the company’s proprietary Trabecular Metal Technology. The studies, conducted by researchers at Osaka City University in Japan, continued investigations into the osteoconductive properties of Trabecular Metal Material in total knee arthroplasty. It is well established that a decrease in bone density may compromise the long-term success of primary total knee replacements and may increase the difficulty and expense of revision reconstruction. Stress-shielding can also exacerbate patients’ osteolytic response to bearing surface particles, potentially further reducing bone density and quality around the implant. Published in The Journal of Bone & Joint Surgery and The Journal of Arthroplasty, the studies found significant reductions in bone loss adjacent to NexGen LPS-Flex monoblock knee implants made with Zimmer’s Trabecular Metal Technology compared to cemented cobalt-chromium tibial components. The studies also noted a significant relative increase in bone mineral density after total knee arthroplasty in patients with Trabecular Metal NexGen LPS-Flex monoblock knee implants.
- Aperion Biologics initiates clinical trial of Z-Lig device for ACL reconstruction
Aperion Biologics Inc. announced the enrollment and implantation of the first patients in the Company’s clinical trial of its Z-Lig Anterior Cruciate Ligament reconstruction device for the treatment of ligament injuries of the knee. The primary objective of the multicenter study is to provide additional evidence of the safety and performance of Z-Lig in the reconstruction of patients’ knees with primary ACL ruptures. Seven sites in Europe and one site in South Africa are participating in this clinical trial. The study results will be used to support regulatory approvals and clinical acceptance of the Z-Lig ACLR device in select markets outside of the United States. "Graft options are limited for ligament reconstruction procedures and Z-Lig could prove to be a tissue alternative which would enhance the world of ACL reconstruction surgeries," said Dr. Willem van der Merwe of the Sports Science Orthopaedic Clinic in Cape Town, South Africa.
- Fibrocell touts results of pilot study for treatment of vocal fold scarring with fibroblasts
Fibrocell Science Inc. (OTC:FCSC), a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today publication of results of a five-patient pilot study evaluating the safety and effectiveness of autologous fibroblasts to treat vocal fold scarring in The Laryngoscope, a peer reviewed scientific journal. The study was conducted by Dinesh K. Chhetri, MD, Associate Professor, Division of Head and Neck Surgery, David Geffen School of Medicine at UCLA, Los Angeles, Calif.