Arthroplasty is a orthopaedic surgery procedure, in which the arthritic or dysfunctional joint surface is replaced with something better or by remodeling or realigning the joint by osteotomy or some other procedure. Previously, a popular form of arthroplasty was interpositional arthroplasty with interposition of some other tissue like skin, muscle or tendon to keep inflammatory surfaces apart or excisional arthroplasty in which the joint surface and bone was removed leaving scar tissue to fill in the gap. Other forms of arthroplasty include resection(al) arthroplasty, resurfacing arthroplasty, mold arthroplasty, cup arthroplasty, silicone replacement arthroplasty, etc. Osteotomy to restore or modify joint congruity is also an arthroplasty.
SI-BONE, Inc., a medical device company that is pioneering the use of a minimally invasive surgical device to treat the sacroiliac joint today announced that iFuse initial post-market clinical experience will be presented at upcoming 2010 minimally invasive spine surgery meetings.
Zimmer Holdings, Inc. today announced the opening of a new Zimmer Institute training center at its Trabecular Metal Technology facility in Parsippany, New Jersey. The Zimmer Institute at TMT will be Zimmer's first full-time BioSkills training center outside of the Zimmer Institute's headquarters in Warsaw, Indiana.
AFFiRiS AG's clinical Alzheimer's vaccine candidate AD02 has already progressed to phase II clinical testing. It may therefore be possible to confirm the efficacy of the vaccine as early as during 2012. Indeed the start of this efficacy study comes only five months after the completion of the corresponding phase I study. The company is active in several disease areas and is currently developing a total of twelve prospective products in all stages of the development pipeline up to clinical phase II.
Facet Solutions, Inc. today announced that it has finished compiling two year data from its lumbar stenosis pilot study in the US. At two years, patients in the ACADIA™ study experienced significant and sustained improvement in Oswestry Disability Index, VAS back pain and VAS leg pain. There were no re-operations in any of the patients, and all patients met the definition of success for ODI improvement.
Acura Pharmaceuticals, Inc. and King Pharmaceuticals®, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application (NDA) for Acurox® (oxycodone HCl and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®.
Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.
LDR, a privately held company with innovative spinal implants for non-fusion and fusion applications, announced completion of the 24-month follow-up phase of its two-level IDE study on the Mobi-C cervical artificial disc. Having previously finalized the 24-month follow-up phase of the one-level study earlier this year, LDR is now the first company to fully enroll and reach two-year follow-up on a concurrent one-level and two-level cervical artificial disc replacement study.
ConforMIS, Inc. announced today that the iUni® G2 has received CE Mark certification, providing regulatory approval for ConforMIS to begin the sale of this products throughout the European Union. The iUni G2 is the next generation of ConforMIS' revolutionary patient-specific knee replacement system, and remains the only patient-specific unicompartmental knee resurfacing implant on the market.
Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, today announced the Company received clearance from the Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology.
Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, today announced its financial results for the fourth quarter and year ended December 31, 2009.
Magellan Spine Technologies, Inc. today announced it had completed enrollment in a twenty patient study to evaluate the Magellan DART (Disc Annular Repair Technology) System for Annular Repair following lumbar discectomy procedures. This first study demonstrates evidence that the DART technology is safe and patients implanted with the DART have excellent outcomes approaching one year follow-up.
The ongoing wars in Iraq and Afghanistan have resulted in uniquely destructive patterns of combat injuries, including limb-threatening injuries to the knee. In the March special issue of Techniques in Knee Surgery military surgeons serving in Operation Iraqi Freedom and Operation Enduring Freedom share their experience with managing these high-energy injuries of the knee. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.
A research team led by Mayo Clinic has found a national trend toward younger, more diverse patients having total knee replacement surgery.
Total knee arthroplasty (TKA) patients may be able to participate in high-impact sports without increasing risk of early implant failure, according to a new study presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).
Hip replacement patients with metal-on-metal (MoM) implants (both the socket and hip ball are metal) pass metal ions to their infants during pregnancy, according to a new study presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons.
Orthopaedic Synergy, Inc., is pleased to announce that it has entered into a letter of intent and period of exclusivity to acquire Praxim, SA of France.
Stryker Corporation's Orthopaedics' division today announced at the American Academy of Orthopaedic Surgeons Conference that its recent FDA-monitored Investigational Device Exemption study found no statistical difference in clinical outcomes between its mobile bearing and traditional fixed bearing knee systems. In contrast, Stryker continues to be very pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers significant advantages over mobile bearing knees on wear rates and overall value.
Ascension Orthopedics, Inc., a leader in orthopedic extremity implants, announces the international market launch of the PyroTITAN™ Humeral Resurfacing Arthroplasty System at the American Academy of Orthopaedic Surgeons Annual Conference in New Orleans, LA, March 9-13, 2010. Designed to meet the unique soft tissue biocompatibility requirements of the shoulder joint, the PyroTITAN humeral resurfacing implant is the first commercially-available, human shoulder arthroplasty prosthesis made of PyroCarbon.
Exactech, Inc., a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company’s Equinoxe® Platform Fracture Stem, the latest addition to the company’s shoulder arthroplasty line.
Amedica Corporation (AC), a spinal and orthopaedic implant and instrument company focused on unique silicon nitride (SiN) ceramic technologies, announced today an agreement with Orthopaedic Synergy, Inc. (OSI), a holding company for OMNIlife Science™ and Enztec, both global designers, manufacturers and distributors of leading edge reconstructive surgery implants and instrumentation.