Bicondylar Knee Implant System Incorporates PEEK-Optima CFR Polymer to Prevent Dislocation

A biocompatible polymer from Invibio is utilised as a bearing material for the axle bearings in a rotational knee system from Aesculap. The material is used to provide wear and cold flow resistance and dimensional stability.

Developed to combat the predominant causes of knee implant failure, luxation, wear and malpositioning associated with metal components, Aesculap's EnduRo knee revision system relies on PEEK-Optima carbon fiber-reinforced (CFR) polymer to increase the implant service life and reduce the necessity of subsequent revision surgery. Through use of PEEK-Optima CFR polymer, the service life of the EnduRo knee implant system’s rotational hinge mechanisms matches that of established primary condylar implants, according to the company.

The EnduRo knee implant from Aesculap


"Aesculap and Invibio have benefited from a long, mutually beneficial relationship based on sharing expertise and knowledge. It was through technical expertise, an understanding of our requirements and a long history of proven biocompatibility and implantation success that Invibio was able to provide us with an exceptional solution," says Dipl.-Ing. (FH) Ulf Grimm, Aesculap Product Manager for Knee Endoprostheses. "Throughout this process Invibio has provided valuable processing support and a manufacturing network with the flexibility and scope to meet our device and time targets,” Grimm adds. “Working with Invibio provided us with both a material and processing solution package that enabled our accelerated time to market requirement.”

The EnduRo knee implant is used in the treatment of severe bone defects and insufficiency of the ligamented apparatus. It has been commercially available in Europe since January 2010 and received US FDA 510(k) clearance in December 2010.

Rensselaer Researchers Develop Postsurgery Orthopedic Implant Sensor

An implantable sensor developed by researchers at Rensselaer Polytechnic Institute (Troy, NY) can transmit data wirelessly from the site of a recent orthopedic surgery. Developed by Eric Ledet, an assistant professor in the department of biomedical engineering, the sensor can provide surgeons with detailed, real-time information from the actual surgery site, an in vivo process that could lead to more accurate assessments of a patient’s recovery or provide information about potential complications.

Measuring only 4 mm in diameter x 500 µm in thickness, the sensor does not require a battery, external power source, or electronics in the body. Instead, it is powered by the external device that is also used to capture sensor data. “Our new sensor will give surgeons the opportunity to make personalized, highly detailed, and very objective diagnoses for individual patients,” Ledet remarks. “The simplicity of the sensor is its greatest strength. The sensor is inexpensive to produce, requires no external power source, yet it is robust and durable. We are very excited about the potential of this new technology.” Having a stream of real-time in vivo data should take some of the approximation and subjectivity out of declaring a patient recovered and ready to return to work, Ledet adds.

Capable of being attached to commonly used orthopedic musculoskeletal implants such as rods, plates, and prostheses, the sensor looks like small coils of wire. Once it is implanted, it can monitor and transmit data about the load, strain, pressure, or temperature of the surgery site. In addition, it is scalable, tunable, and easy to configure, enabling it to be incorporated into many different types of implantable orthopedic devices.

Report: Hundreds of thousands exposed to toxic compounds from metal-on-metal hip implants

Hundreds of thousands of patients may have been exposed to toxic chromium and cobalt particles as their metal-on-metal hip implants wear, according to a joint investigation by the British Medical Journal and BBC Newsnight.


Hundreds of thousands of patients may have been exposed to toxic compounds from metal-on-metal implants, according to an investigation by the British Medical Journal and BBC Newsnight, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA.

The implants, including Johnson & Johnson's (NYSE:JNJ) DePuy ASR and Pinnacle, Smith & Nephew's (NYSE:SNN) Birmingham and Zimmer's (NYSE:ZMH) Durom, release particles of their chromium-cobalt alloy as the metal parts wear against each other, causing tissue and bone death and possibly exposing patients to the risk of developing cancer or even altering their DNA.

"Despite the fact that these risks have been known and well-documented for decades, patients have been kept in the dark about their participation in what has effectively been a large, uncontrolled experiment," according to the report.

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:

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.

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.