March 10th, 2010 by OS
About Orthopaedic Synergy, Inc.
Orthopaedic Synergy, Inc. functions as a holding company for OMNIlife Science, Inc. and Enztec, Ltd. Together these companies represent a global reconstructive orthopaedic concern that is committed to the design, manufacture and distribution of high quality orthopaedic devices. Our corporate strategic objectives include continued growth through strategic acquisition of companies with complementary technology to enhance the development of line extensions to our company’s current product offerings as well as the introduction of new products that will allow us to provide new and improved clinical options for our customers.
About Praxim, SA
Praxim develops and commercializes advanced automated systems, software and instruments used by surgeons in the operating room to make total joint arthroplasty less-invasive, faster, more reliable and cost-effective for both patients and surgeons. The Company’s technology platforms such as the I-block surgical robot, Nano-station Computerized Surgical navigation system, and Nano-block manual surgical instruments for computer assisted surgery address key issues associated with conventional joint replacement surgical procedures – including incorrect sizing and positioning of joint replacement components that can lead to misalignments of bones ultimately leading to joint replacement failure. These can be avoided by providing highly innovative imaging protocols and advanced smart instrumentation in the operating room.
PRNewsWire…. http://ow.ly/1gh9y
March 9th, 2010 by OS
Orthofix International N.V. announced today it has sold the assets of its vascular business, including its AV-Impulse(R) mechanical compression technology, to Covidien.
“This transaction represents another important step towards focusing Orthofix on strategic market segments that represent long term growth potential for the Company,” said Orthofix’s CEO Alan Milinazzo. “Additionally, the proceeds from the sale of this business will allow us to further deleverage our balance sheet.”
As part of the sale, Orthofix has agreed to provide transitional services to Covidien for a period of up to five months. Additionally, under the terms of two Supply Agreements, Orthofix will provide Covidien with 2-years’ worth of Impads used in conjunction with the compression therapy devices being sold, as well as with additional products relating to this business for a 90 day period.
StreetInsider… http://ow.ly/1ggWd
March 9th, 2010 by OS
Gamma Spine, founded by Dr. Vijay Goel, Ph.D., will participate in the development process with X-spine. “I am thrilled be working with Dr. Goel, who is one of the world’s most renowned and published experts in spinal biomechanics, to develop this unique and valuable technology,” stated Dr. David Kirschman, President and CEO of X-spine. The patent-pending device allows for the fixation of adjacent vertebral segments with minimal tissue disruption while attaining the biomechanical advantages of a traditional full-exposure system.
BusinessWire… http://ow.ly/1ggHi
March 8th, 2010 by OS
PearlDiver projects extremities sales will grow to $1.5 billion by 2012, with Tornier holding the No. 2 market-share spot behind DePuy Orthopaedics. See PealDiver’s projects below.
March 8th, 2010 by OS
The PyroTITAN Humeral Resurfacing Arthroplasty System is the first commercially-available, human shoulder arthroplasty prosthesis made of PyroCarbon. Available in twelve sizes, PyroTITAN is intended to address glenohumeral joint disease due to non-inflammatory, inflammatory and post traumatic arthritis by replacing the damaged humeral head bearing surface and restoring patient anatomy while preserving bone. This system provides size-specific, color-coded, cannulated instrumentation for ease of use and reproducibility.
“We are very excited about the addition of the PyroTITAN Humeral Resurfacing Arthroplasty System. This first commercially-available PyroCarbon implant for shoulder arthroplasty demonstrates the company’s leadership role in extremity orthopedics. It also underscores our commitment to pioneer applications of PyroCarbon to address the challenges faced by our surgeons and the specific needs of their patients with joint disease,” states Guy Mayer, CEO.
Ascension’s commitment to PyroCarbon technology is based on the material’s enhanced wear resistance and biocompatibility against native bone and cartilage; and its clinical survivorship compared to other bearing surfaces such as cobalt chrome, titanium and ceramic. Native joints have been shown to lubricate through the adsorption of surfactant (surface-active phospholipid) to cartilage, which provide boundary layer lubrication. Similarly, the adsorption of surfactant and other biological molecules to the surface of PyroCarbon offers a boundary layer lubrication mechanism for the favorable wear characteristics of PyroCarbon against both itself in total joint replacement and against native cartilage or bone in partial joint replacement.
PRNewsWire… http://ow.ly/1fBhf
March 5th, 2010 by OS
The FDA wants a “do-over” for ReGen’s Collagen Scaffold clearance. Will this be the beginning of the company’s resurrection or will it be the final nail in the coffin?
The agency has called a meeting of their orthopedic device panel on March 23 to “discuss and make recommendations on issues relevant” to the agency’s reevaluation of its previous clearance of ReGen’s product.
The entire medical device industry should be watching this like hawks. ReGen won FDA clearance for its device last year after this same panel said the device was safe.
To the credit of new leaders of the FDA, the agency issued a stinging self critique last year of its handling of the Collagen Scaffold. That criticism pointed to its own bureaucratic and internal political faults and nothing about the product’s safety or any specific allegations of unlawful or improper behavior by the company. The criticism also spawned a review of its entire 510(k) process.
OTW… http://ow.ly/1eCtp
Sept 2009 FDA: Menaflex Clearance Shows “Definite Threats” to the 510(k) Process
Sept 2009 FDA is talking tough about pulling back its clearance of ReGen’s Menaflex
March 4th, 2010 by OS
ADM Mobile Bearing Acetabular System with X3 Advanced Bearing Technology Designed to Reduce Complications Associated with Total Hip Arthroplasty
While total hip replacement is one of the most successful surgical procedures performed today, dislocation remains one of the top reported complications(1). To address dislocation, conventional designs focus on the use of metal-on-metal large head technologies which based on recent studies suggest added risk due to metal ion release(2). Combining an evolution in design with the only anatomic dual mobility acetabular system and its patented X3 Advanced Bearing Technology(3), Stryker Orthopaedics Mobile Bearing Hip addresses dislocation without the risk of metal ion release.
“By developing an implant that addresses adverse outcomes associated with hip replacement surgery, we are not only helping surgeons to treat their patients more successfully, but we are also striving to reduce global healthcare costs by minimizing surgical complications,” said Bill Huffnagle, Vice President and General Manager of Hip Reconstruction at Stryker Orthopaedics.
This Mobile Bearing Hip system is made possible due to Stryker Orthopaedics’ patented X3 Advanced Bearing Technology(3) which is designed to increase the longevity of the implant. Laboratory tests have shown a 97% reduction in volumetric wear compared to conventional polyethylene(4). ADM’s anatomic design also has the potential to increase mobility and reduce groin pain(5)(6). Its dual points of articulation help accommodate multi-directional movement, which provide greater range of motion than fixed implant designs based on laboratory testing(5). In addition, the anatomic cup design has an iliopsoas tendon cut-out aimed at reducing iliopsoas tendon impingement(6), a key cause of post-operative groin pain.
PRNewsWire… http://ow.ly/1eide
March 4th, 2010 by OS
The screws used by doctors to repair broken bones and torn ligaments enable recovery from a wide range of injuries. Unfortunately, they also leave holes in bones, require secondary surgery for removal, and make going through airport security a real pain. But by crafting the screws from a special designed composite of polymer and mineral, researchers at Germany’s Fraunhofer Institute have managed to solve all those problems in one fell swoop.
The researchers make the screws from a combination of polylactic acid, a biodegradable polymer already used to make surgical implants, and hydroxyapatite, the mineral that forms 50 percent of natural bone.
Like existing screws, the polylactic acid dissolves harmlessly in the body, saving patients the second surgery required for the removal of the older, stainless steel screws. Also, unlike regular polylactic acid screws, which leave gaping holes in bone, the hydroyxapatite interacts with the surrounding tissue to promote bone growth that naturally fills in the holes made by the screws.
And that’s not all! Manufacturing the screws out of the hydroxyapatite composite also simplifies production. Molding a pure polylactic acid screw requires temperatures around 2552 degrees Fahrenheit. By comparison, the mold for the hydroxyapitate composite screw only needs to reach 284 degrees, saving time, money, and energy.
Cheaper, healthier, and more energy efficient? Wow, Chalk one up for German engineering.
Popular Science… http://ow.ly/1ehWH
March 4th, 2010 by OS
Some of the nation’s leading orthopedic surgeons have reduced or stopped use of a popular category of artificial hips amid concerns that the devices are causing severe tissue and bone damage in some patients, often requiring replacement surgery within a year or two.
Quoted are… Dr. Young-Min Kwon (MGH), Dr. Joshua J. Jacobs (Rush), Dr. Daniel J. Berry (Mayo), Dr. Harlan C. Amstutz (LA), Dr. Brett Levine (Rush)
NYTimes.. http://ow.ly/1e6pV
March 3rd, 2010 by OS
Clara Frias has created this “intelligent” hip device in order to detect an implant’s eventual problems and to stimulate bone growth, thus improving the quality of life for patients and reducing the risk of further surgery.
The Smart Hip is a network of capsules, measuring sensors and actuators that are placed on the hip implant. Once activated by the doctor — through a computer connected to a Bluetooth device — the “Smart Hip” components send information that can help prevent eventual problems after surgery.
To monitor the real-time performance of bone implants is the challenge of “Smart Hip,” an innovative medical device that aims to reduce the number of surgical interventions in the hip area and regenerate bone tissue by using non-evasive methods. The device has already been successfully tested on animals.
ScienceDaily… http://ow.ly/1dDuW
