29 февр. 2012 г.

Hydroxyapatite Biomaterials Explore New Applications in Coatings and Bone Cements

A new range of hydroxyapatite (HA) biomaterials have potential new uses in antimicrobial and osteopromotive coatings. They could also be used in the development of bone cements with altered structural features that include toughness, solubility, and porosity. Developed by Ceram, the materials have different biological properties. The company changed the basic chemistry of the material, while keeping its physical structure, by putting different elements into HA.
Ceram has filed a patent on the material and is looking for manufacturing partners. It is also open to forming agreements with research institutions to find new applications for the material.

Offset Reamer Driver

Symmetry Medical Inc. has announced that it has launched the Offset Reamer Driver through its OEM Solutions team. Symmetry’s new Offset Reamer Driver is used in minimally invasive surgical techniques, such as the direct anterior approach, to introduce acetabular reamers to the hip joint. The driver features a drive shaft designed and tested to meet the demands of Total Hip Athroplasty (THA) surgery. The product highlights include:
• Acetabulum access is improved due to the low-profile reamer/driver interface connection
• Features an ergonomic silicone overmolded handle
• Compatible with all of Symmetry’s flagship acetabular reamers and together with the Split-Thread Cup Impactor launched last year further expands the Company’s minimally invasive line of hip arthroplasty instruments

For more information, visit www.symmetrymedical.com.

Alexander Orthopaedic Associates Chooses White Plume Technologies to Fill the EMR Gap

Alexander Orthopaedic Associates (AOA) in Largo, FL, has chosen to fill the EMR Gap in their practice with White Plume Technologies between Exscribe electronic health record (EHR) and Advanced Data Systems' (ADSC) practice management system (PM system).

EMRs can be powerful clinical tools but often leave gaps in the billing process unfilled. White Plume Technologies bridges EMR gaps by specializing in accelerating the physician charge capture and medical coding process.

Dr. Allan Alexander of Alexander Orthopedic Associates, an EMR user since 2002 and White Plume client since 2005, explains how White Plume fills the EMR gap:

28 февр. 2012 г.

DePuy receives FDA premarket supplemental approval for TRUMATCH system

DePuy Orthopaedics Inc. has received premarket supplement approval from the FDA for use of TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System. The system was previously cleared in Aug. 2011 for the SIGMA Fixed-Bearing Knee System, making DePuy the only orthopedic company to offer personalized instrumentation for use with both rotating platform and fixed bearing knee prostheses, according to a company release.


“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” Andrew Ekdahl, president of DePuy Orthopaedics, stated in the release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room,” he stated.

TRUMATCH Personalized Solutions, according to the release, is a surgical instrumentation and computer software system designed to aid both knee implant positioning and procedure efficiency.
Report Slams Response to Metal Hip Troubles

By John Gever, Senior Editor, MedPage Today

Published: February 28, 2012


Regulators on both sides of the Atlantic were slow to inform patients and their doctors about problems with metal-on-metal hip implants and relied on industry officials and consultants in crafting their responses, the BMJ charged.

According to a report appearing online in BMJ, regulators in the U.K., the U.S., and elsewhere should have prevented "a whole class of failing hip implant [sic] from being used in hundreds of thousands of people globally."

The report is based on an investigation commissioned by the journal and the BBC's Newsnight program.

BMJ investigations editor Deborah Cohen reported that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) first became aware of problems with metal-on-metal implants in 2006, but it was not until 2010 that the agency issued a formal warning to physicians and the public. Complications included high failure rates and possible systemic effects from elevated metal ion levels in the blood.
 
Sandvik Medical Solutions Acquired by Orchid Orthopedic Solutions

Sandvik (Sandviken, Sweden) has reached an agreement with Orchid Orthopedic Solutions (Holt, MI, USA) to divest Sandvik Medical Solutions, a unit within the Sandvik Venture business area with contract manufacturing of medical implants and instruments for orthopaedic and dental applications. “The divestment of Sandvik Medical Solutions is in line with our strategy to exit operations outside of the defined core businesses. There is a strong industrial logic in combining Orchid and Sandvik Medical Solutions,” said Anders Thelin, president of Sandvik Venture.

“The combination of Orchid and Sandvik Medical Solutions will have a unique offering to its customers and become the leading orthopaedic implant supplier globally. The acquisition also demonstrates Orchid’s commitment to be a leader in a consolidating industry,” said Claes Ekstrom, Board Member in Orchid and Partner at Altor Equity Partners.

The divestment is expected to be concluded in March 2012.

27 февр. 2012 г.

Osseon® Announces International Distribution Agreement with Aesculap

Osseon® Therapeutics, Inc. announced today that the company has entered into an International Distribution Agreement with Aesculap AG to distribute its vertebral compression fracture (VCF) treatment devices, including its new CE-Mark approved device – Osseoflex® SB (steerable balloon) in select regions of Europe and Asia. Aesculap is a division of B. Braun Melsungen, a large medical and pharmaceutical company headquartered in Tuttlingen, Germany. The Osseoflex® SB and the other Osseon CE Mark approved VCF medical devices offer a complete platform for treatment of spinal fractures.

"Aesculap is a major medical device company known throughout the world as a quality manufacturer and distributor of surgical instruments. Our new Osseoflex SB (steerable balloon) represents the most precise and controllable treatment device for vertebral compression fracture augmentation currently available to surgeons. Osseon is very excited to partner with Aesculap to distribute our game-changing Osseoplasty® devices and procedures for VCF treatment to patients throughout Europe and the international community and provide state-of-the-art alternatives to the cumbersome devices and procedures currently used to treat fractures of the thoracic and lumbar spine," said John Stalcup, Ph.D., Osseon's CEO.

25 февр. 2012 г.

Blue Belt Technologies Receives CE Mark for Navio PFS System

Blue Belt Technologies, Inc., a medical device company focused on developing the next generation of "smart" surgical instruments providing precise robotic control for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology ("ENT"), announced today that it has received CE Mark for the Navio™ PFS System.

The Company's initial market application in Europe is for Unicondylar Knee Replacement ("UKR") which is commonly known as partial knee replacement. A partial knee replacement is surgery to replace either the inside (medial) or outside (lateral) compartment of the knee with an implant. Partial knee replacements are bone-sparing and have been shown to provide better surgical outcomes for patients with cartilage damage contained to a single compartment when compared to total joint replacement. The majority of partial knee replacement surgeries are currently performed using instruments which can be inconsistent and lead to high revision and retreatment rates.
Technique, patient and implant selection key to avoiding fracture during THA

At the Current Concepts in Joint Replacement 2011 Winter Meeting, Craig J. Della Valle, MD, provided tips on the prevention of intraoperative fractures during total hip arthroplasty.

“Prevention is key,” Della Valle said, noting that appropriate exposure is crucial.

In a study of more than 5,000 hip replacements performed by 11 surgeons during a 10-year period, Della Valle and colleagues found that risk factors for fracture include elderly patients, female patients and type of stem used. He noted that flat-wedge taper designs have a high risk for early postoperative and intraoperative fracture. Developmental dysplasia of the hip was also substantial risk factor.


The decision to use a cemented or uncemented implant is also key.
Hip resurfacing: The metal-on-metal bearing material is not the problem

The success of total hip replacement (THR) in the 20th century has been tremendous with improvements in the durability of new designs, bearing materials and fixation techniques. However, the young and active patients have historically had high revision rates compared with older, more sedentary patients, notably when the etiology of the disease is osteonecrosis. Despite great improvements in cementless stem fixation, hip resurfacing arthroplasty (HRA) has the advantages of replicating leg length and offset, and maintaining proximal bone unlike THR. Moreover, dislocation in THR remains a problem when small femoral heads are used. Resurfacing patients also do not report thigh pain as it sometimes happens after THR.

When it comes time for revision surgery, as should be expected for most young and active patients, whether treated with a resurfacing or a primary THR, the preserved bone stock with hip resurfacing provides more favorable conditions for a successful surgery and the technical difficulty of the conversion is comparable to that of a primary THR. This enables patients seeking to restore their previous lifestyle to be more active than with a THR, and numerous authors have reported high levels of physical activity in patients after hip resurfacing.