Orthopedic News Roundup 9-Sept-05
BY HUYEN NGUYEN, SEPTEMBER 9, 2005
The FDA Orthopedic and Rehabilitation Devices Panel held a meeting September 8th and 9th to rule on two important issues: Smith & Nephew's hip resurfacing device and the design of clinical studies for spinal devices. You can find background information on this meeting here.
Acquisition: Integra LifeSciences, a neurosurgery and reconstructive surgery company, announced that it has acquired the assets of Radionics, a division of Tyco Healthcare Group, L.P. for $80 million in cash. Radionics manufactures and develops minimally invasive medical instruments in the fields of neurosurgery and radiation therapy. An Icelandic orthopedic bracing company, Ossur hf announced the intention to acquire a European orthopedic company for $20 million; name of the company was not disclosed.
Appointment: The worldwide manufacturer, developer and distributor of orthopaedic implants, Smith & Nephew has appointed Dr. Peter Heeckt as Chief Medical Officer for its Orthopaedics division in Memphis, Ten. Dr. Heeckt previously served as medical director for Fresenius ProServe, a German healthcare company. An orthopedic trauma company, Orthofix International N.V. has hired Alan W. Milinazzo as chief operating officer (COO) for the Company. Previously, Mr. Milinazzo was from Medtronic Inc., where he was Vice President of Medtronic's Vascular business. Here's our comment on this press release. An orthopedic bracing and soft goods company, Langer, Inc. has appointed W. Gray Hudkins to the position of President and Chief Executive Officer. Mr. Hudkins is currently the Company's Chief Operating Officer. Andrew H. Meyers, its current President and Chief Executive Officer, will step down effective December 31, 2005, when his position is set to expire.
Regulatory Update: The Japan Ministry of Health Organization for Pharmaceutical/Medical Device Safety and Research (OPMDSR, also known as "KIKO") has approved for Kyphon to begin enrolling patients to treat spinal fractures with the balloon kyphoplasty procedure. The enrollment is expected to start before the end of this year through 2006 with 80 patients in six centers. A synthetic biomaterial company, CeraPedics has filed for an Investigational Device Exemption (IDE) with the FDA to conduct clinical trials on its P-15™ synthetic bone graft in cervical spine fusion surgery. At the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting, the FDA granted Smith & Nephew pre-market approval application (PMA) for its Birmingham Hip Resurfacing (BHR) technology. However, the Company is required to do a post marketing trial follow-ups.
Distribution & Licensing Agreement: An allograft company, IsoTis Biologics entered into a three year non-exclusive distribution agreement with Lifetek LLC and Endoplant AG, both are subsidiaries of PLUS Orthopedics Holding AG. Under the agreement, Lifetek will market and sell IstoTis' DynaGraft® II and OrthoBlast® II under the brand names Nexus and Nexus IC in other countries beside Europe. PLUS sales organization will sell IsoTis' products in Europe. As part of a 2001 patent infringement settlement, ArthroCare and Smith & Nephew have announced a distribution and manufacturing agreement regarding ablation products used in arthroscopic or minimally invasive surgery of the joints. Read our analysis of this distribution agreement.
Legal: The Federal District Court for the Western District of Tennessee ruled in favor of Smith & Nephew plc against Synthes regarding a patent infringement suit over the dispute relating to intramedullary nails. The suit was filed in November 2002 by Smith & Nephew claiming that Synthes Synthes' Trochanteric Fixation Nail (TFN) and Proximal Femoral Nail (PFN) products infringed patents owned by Smith & Nephew.
Product Update: CryoLife's BioDisc™ device was successfully implanted into two patients in the United Kingdom. The BioDisc™ is a nucleus polposus repair device intended to treat patients with herniated disc after a discectomy in the lumbar region of the spine.
Miscellaneous: If you want to test your skills on famous people in orthopedics, here's a book you can pick up from Springer publication. Doctors now can take a quick break from doing rounds by replacing themselves with robots. What are the proper treatments for tennis elbow? Sports medicine doctors seem to disagree on one unified solution. In today's society, our dependency on computers is just as trivial as food. In the operating room, orthopedic surgeons are utilizing computers and its technology to perform smaller incision-hip replacement surgery. You can watch this live surgery on September 13th, 2005 at 2:00PM EDT. At the Institute of Parasitology and Biomedicine of the Spanish National Research Council (CSIC), in Grenade, a team of scientists have develop a cellular therapy for rheumatoid arthritis and multiple sclerosis.
