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Cambridge Polymer Group and Massachusetts General Hospital have co-developed novel, highly crosslinked ultra high molecular weight polyethylenes that incorporate vitamin E and are suitable for hip, knee, shoulder and spine arthroplasty applications. These technologies, generically termed CIMA, E-CIMA and Reservoir Vitamin E, are available for license.

E-CIMA

E-CIMA is a formulation containing Vitamin E throughout the material. Following blending and consolidation, the sample is subjected to ionizing radiation, which forms crosslinks in the material. The material is then deformed at a temperature below the melting point to quench residual free radicals. An annealing step returns the sample to its original shape, after which it is ready for machining into an implant. E-CIMA has wear properties similar to remelted, highly crosslinked UHMWPE, yet has the improved mechanical properties approaching virgin UHMWPE. Coupled with this is the oxidative resistance of Vitamin E.
This patented material is available for licensing. One licensee, Corin Group, published on E-CIMA properties at the 2011 Orthopedic Research Society meeting.

(2/9/2012 update): Corin has announced that they received FDA clearance on E-CIMA (product name eCiMA).
CIMA

CIMA is similar to E-CIMA, but does not incorporate Vitamin E into the UHMWPE matrix. This material provides good wear, good mechanical properties, and improved oxidation stability over annealed highly crosslinked UHMWPE.

Reservoir Vitamin E

The Reservoir Vitamin E is a surface crosslinked UHMWPE that contains Vitamin E in specific locations, allow targeted crosslinking in regions where wear rates must be control, yet high mechanical properties in regions where locking mechanisms are located. This material has excellent applications for re-surfacing or thin liners in orthopedics, and is available for licensing.


Contact Cambridge Polymer Group for information about properties, licensing and regulatory approval.

CPG will have an exhibit at the upcoming annual meeting of the Orthopedic Research Society in San Francisco, CA, from February 4th to February 7th. This conference brings researchers, medical device manufacturers, surgeons, and regulatory agency representatives together to discuss the latest technologies, practices, and clinical outcomes in the area of orthopedic surgery, including hip, knee, spine, shoulder, ankle, and other joint spaces. Come visit us to learn about the latest work we are doing in this growing area.

More information

When marketing a new product, differentiating your product from your competition can be a nuanced activity, depending on the nature of the product. In more tightly regulated markets, customers may require side-by-side comparisons of their existing approved and validated products with your new offering, to ensure that it has the same or better properties. As they have usually gone through some time and expense to validate the product, be it a raw material or finished good, and they bear a risk in changing, you need to demonstrate that the risk is worth it in terms of cost-savings or improved performance.

At Cambridge Polymer Group, we often assemble and perform a set of standard or customized tests that helps the client highlight the key performance traits of their product, while also demonstrating that the root level performance characteristics meet or exceed what their customer is currently using. Whenever possible, we use ASTM standard tests in the relevant industries to assemble a single page of testing results that your sales group can provide to customers. We perform these tests in our ISO-certified laboratory, so you can be assured of the quality and un-biased nature of our results.

The U.S. Senate has introduced a bill that allows the FDA to require medical device companies to collect and track data on the clinical performance of their marketed devices, such as hip and knee replacements. This action is in part due to the on-going reported issues of metal-on-metal hip implants failing due to metal ion sensitivity, which some studies have shown lead to the formation of pseudo-tumors. Advocates for this data collection suggest that the information will be useful for the on-going 510(k) regulatory approval process for new devices that have similar characteristics to already marketed devices, for-going the need for clinical studies necessary in a full PMA process.

Cambridge Polymer Group is now partnered with Pulse Anatomy to produce custom anatomy models made from our patented materials for use in clinical device development and professional education. Pulse replicates the anatomy using digital data as a starting point for the process of printing of rapid prototyped parts, creating molds and producing castings. Pulse's team includes digital designers, mechanical and electrical engineers, artists, sculptors, model makers and machinists. The process of developing a model with the Pulse and Cambridge Polymer Group team is a collaborative effort with our clients to ensure the final product meets the clients criteria. Please visit Pulse Anatomy for more information on model choices, or contact CPG.

Our tissue models can be fabricated from silicone, polyurethane, or tissue-mimicking hydrogels using our patented formulations.

PEEK finds itself increasingly being used in medical device applications due to its strength, biocompatibility, resistance to radiation and degradation, and ease of processing. CPG has been providing testing services on PEEK for our clients for several years, including crystallinity assessment by DSC and FTIR, mechanical properties, surface morphology characterization, and rheological characterization. CPG now offers gel permeation chromatography assessment of molecular weight distribution of PEEK.