23 March 2012
Next generation vitamin E highly cross-linked polyethylene gains FDA clearance
Corin adds the next generation vitamin E polyethylene to its high performance bearing options for the Trinity™ advanced acetabular system following FDA 510(k) clearance.
In February, Corin received 510(k) clearance from the FDA for ECiMa™ highly cross-linked polyethylene liners to be used in combination with the large diameter Cobalt Chrome and BIOLOX® delta ceramic heads (up to 40mm) for its Trinity™ acetabular system.
This announcement marks another significant step forward for Corin's hip portfolio in the US following a number of 510(k) clearances in 2011, which enables the company to offer a range of high performance bearing solutions within a versatile Continuum of Hip Care to surgeons across the country. Corin's Continuum of Hip Care offers the surgeon the ability to select the right implant for a broad spectrum of patient indications with a range of choices that focus on bone conservation, hip stability, fixation and wear. Today's patient population is placing greater demands on their hip replacements and the ability to address individual surgeon and patient requirements is a fundamental part of a modern day hip portfolio.
ECiMa™ represents the world’s first highly cross-linked vitamin E polyethylene which is mechanically annealed, preserving the mechanical properties such as strength whilst achieving extremely low wear1,2. Studies show that ECiMa™ reduces wear in a 40mm bearing by 95% compared to a standard 32mm polyethylene bearing. When compared to a first generation highly cross-linked polyethylene, used by many major orthopaedic companies, ECiMa™ reduces wear by 83%1. The ultimate tensile strength of ECiMa™ is also comparable to that of standard polyethylene and is a 45% improvement on the first generation highly cross-linked polyethylenes2. These excellent wear characteristics and mechanical properties allow the use of optimised bearings to help restore function to the hip and help provide the potential for better long-term results for patients.
The ultimate benefit of ECiMa™ is generated through the active stabilisation provided by the blended vitamin E which has been shown through various studies to provide ongoing protection against oxidation of the polyethylene whilst in the hip joint. The free radical stabilisation effect of vitamin E provides a natural barrier to potential long-term oxidation which can occur in vivo. Test results show no evidence of oxidation following intensive ageing and cyclic loading in vitro where previous HXLPE liners have failed3.
Katherine Granger, Corin's Global Head of Hip Marketing, commented "ECiMa™ is an excellent addition to the Trinity™ acetabular system offering surgeons and patients the most advanced bearing technology within an innovative system. ECiMa™ is the next generation vitamin E-enriched technology and the most advanced polyethylene on the market, providing a high performance alternative to hard bearings. As such, future plans include the roll-out of ECiMa™ to some of our knee products, and others, across Corin’s wider portfolio.”
References:
1. Traynor A, Simpson DJ, Collins SN. Vitamin E HXLPE for low wear and oxidation resistance of hip bearings. International Society of Biomechanics. Brussels. July 2011.
2. Data held on file Corin Group PLC.
3. Data held on file Corin Group PLC.
For further information about Corin Group PLC, please visit www.coringroup.com.
17 February 2012
In spite of a difficult economic climate, Mathys improved its currency-adjusted sales by 7 % in 2011 while the number of employees remained stable.
The orthopaedics company Mathys, based in Bettlach, can look back on a successful but challenging year. The family-owned company posted consolidated sales of CHF 111.2 million in 2011. "Currency-adjusted real growth was 7 % because, as an export-centric company, we are still affected by the currency crisis," explains Dr. Arne-C. Faisst, CEO of the Mathys Group. The company lost around CHF 7.8 million to currency effects. While the weak euro could still be countered relatively well by productivity increases in 2010, the weakness of the dollar made things worse in 2011 and created a difficult situation for Swiss manufacturers that benefited their American competitors. "The US manufacturers pass on the currency gains directly to the markets in the form of price cuts. This made our situation more difficult," explains Arne Faisst. The company nevertheless posted double-digit growth in some countries. While sales improved by 30 % in the home market Switzerland, the family-owned company also generated double-digit growth in France, the Netherlands, Austria and Australia.
Number of employees remained stable
The number of employees remained stable in spite of the economic challenges. Mathys currently employs 465 persons, 274 in Switzerland and 191 at its eleven subsidiaries worldwide.
Japanese subsidiary becomes operational
The Japanese subsidiary established in 2009 will go operational in 2012. "Product registration in Japan has kept us very busy the past two years. As planned we can now start selling our products in Japan this year – the first Japanese patient received a Mathys hip prosthesis back in January," says a delighted Arne Faisst. With Japan and China, Mathys is now represented in two important Asian markets.
Outlook
The outlook for this year is positive. As the company’s ongoing investments in innovative products are now bearing fruit and excellent clinical results on various products are leading to a full product pipeline, the Executive Board expects the current momentum to continue. Mathys expects solid growth for 2012, too.
General Information about Mathys Ltd Bettlach
The Swiss Orthopaedic company was founded in 1946 and looks back on 50 years of experience in the field of medical technique. Since 1 November 2003 Mathys concentrates solely on the development, production and supply of joint replacement products, produced predominantly in Switzerland and also in Germany. The company currently focuses on implants for hip, knee and shoulder and in addition synthetic bone replacement material.
The company has 11 Subsidiaries in Germany, France, Belgium, the United Kingdom, Holland, Austria, Australia, New Zealand, P. R. China, Japan and Switzerland and is owned by the families Mathys and Marzo. Hugo Mathys holds the position of Chairman of the Board of Directors; Dr. Arne Faisst is CEO and Chairman of the Executive Board.
Question should please be addressed to:
Regula Haag, Head Corporate- and Market Communication
Mathys Ltd Bettlach, Güterstrasse 5, P. O. Box, 2544 Bettlach, Switzerland
Telephone direct: +41 (0)32 644 14 97
Mobile-Nr.: +41 (0)79 593 89 35
Fax direct: +41 (0)32 644 14 60
E-mail: regula.haag@mathysmedical.com
Switchboard: +41 (0)32 644 1 644