FDA Approval

Link  http://www.govhealthit.com/online/news/350502-1.html

By Peter Buxbaum  Published on August 4, 2008

The Food and Drug Administration has proposed a program that would query public and private databases to help study the efficacy of orthopedic implants.

FDA will issue a request for quotations next month in an effort to identify companies that could evaluate orthopedic implant registries for participation in the program.

The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader effort is intended to monitor and provide early warnings of potential problems with FDA-approved medical products.

The implant program would “create a national network of registries for the FDA in support of the Sentinel Initiative,” according to an FDA announcement posted July 25. Implants of interest would include total hip, total knee, hip resurfacing, intervertebral disc implants and ankle devices.

The program would create a distributed network to enable FDA to query multiple data sources for information about medical products. As envisioned, queries to the network would be accomplished with minimal data transfer and would protect patient privacy.

FDA’s current post-market surveillance programs require “health care professionals and patients to first recognize an association between an adverse effect and a medical product, and then report it to FDA,” an FDA spokesperson said. “Most adverse events are never reported, and when they are, the information provided is incomplete.”

FDA officials envision being able to search government databases, such as the Medicare database, private and public medical claims databases, and electronic health record systems, the spokesperson said.

The proposed evaluations of the orthopedic implant registries will lead to recommendations for involvement of the most promising data sources, the FDA announcement states.

The Sentinel Initiative “could also ultimately facilitate data mining and other research-related activities,” the spokesperson added.

Link 

http://phx.corporate-ir.net/phoenix.zhtml?c=118965&p=irol-newsArticle&ID=1098406&highlight=

Stryker Issues Statement Regarding FDA Warning Letter

KALAMAZOO, Mich., Jan. 22 /PRNewswire-FirstCall/ -- Stryker Corporation (NYSE: SYK) today issued the following statement in response to recent media attention regarding a Warning Letter dated November 28, 2007, that the United States Food and Drug Administration (FDA) published on its web site on January 15, 2008.

While Stryker does not normally comment on discussions with the FDA, the Company believes it is obligated to provide additional information to healthcare professionals, providers and patients in light of several media reports that draw erroneous conclusions surrounding the Warning Letter.

Most importantly, the Company does not believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients. Numerous published independent reports validate the long-term clinical performance of these products.

The Company takes these matters very seriously and has been cooperating fully with the FDA to address questions related to the FDA's observations of Stryker's internal process specifications. As part of a comprehensive review of internal processes following the FDA's observations, the Company conducted an investigation into a deviation from its internal specifications and processes for the Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork, Ireland facility.

The internal investigation confirmed that all Trident Acetabular products manufactured in Cork, Ireland, have met all U.S. and international performance standards for sterility and biocompatibility. However, results from that testing indicated that the level of manufacturing residuals in some cases exceeded the Company's internal acceptance criteria. It is important to note this in no way impacts the product's sterility, nor product conformance to U.S. and international biocompatibility standards. As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility. Medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products. In fact, independent clinical evidence confirms that the performance of these cups compares very favorably with other high performing acetabular devices.(1,2,3)

Trident Acetabular Cups manufactured in the Company's Mahwah, New Jersey facility are not part of the voluntary recall and are still available to supply Stryker's customers.

The Company anticipates some short-term supply disruption as a result of this action and is focused on eliminating these disruptions as expeditiously as possible. In that regard, the manufacturing process for these cups in Cork has now been validated, product shipments have resumed and the Company has increased production at both the Mahwah and Cork facilities. Quality is a Stryker core value and the Company remains committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations, including those administered by the FDA and regulatory bodies in other countries in which Stryker conducts business.

The Company does not anticipate any material financial impact on Stryker's guidance for its 2008 results as a result of this voluntary recall. Details regarding the Company's sales and earnings outlook will be provided in conjunction with the release of its fourth quarter 2007 operating results on Wednesday, January 23, 2008.

Forward-Looking Statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause the Company's actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for the Company's products; regulatory actions; unanticipated issues arising in connection with clinical studies and eventual FDA approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; changes in economic conditions that adversely affect the level of demand for the Company's products; changes in foreign exchange markets; changes in financial markets; and changes in the competitive environment. Additional information concerning these and other factors are contained in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; and endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at www.stryker.com.

1. 2006 Annual Report of the Australian Orthopaedic Association. Retrieved
January 21, 2008, from http://www.aoa.org.au/docs/njrrrep06.pdf

2. Capello WN, D'Antonio JA, Manley MT, Feinberg JR. Arc-deposited
hydroxyapatite-coated cups: results at four to seven years. Clin
Orthop Relat Res. 2005 Dec; 441: 305-12.

3. D'Antonio JA, Manley MT, Capello WN, Bierbaum BE, Ramakrishnan R,
Naughton M, Sutton K. Five-year experience with Crossfire highly
cross-linked polyethylene. Clin Orthop Relat Res. 2005 Dec; 441: 143-
50.



SOURCE Stryker Corporation
CONTACT: Investors, Katherine A. Owen, Vice President, Strategy and
Investor Relations, +1-269-385-2600, Media, Aaron Kwittken, +1-646-747-7144,
stryker@kwitco.com, both of Stryker Corporation/
/Web site: http://www.stryker.com
http://www.aoa.org.au/docs/njrrrep06.pdf /
(SYK)

FDA Warning Letter to Stryker about hip device problems and manufacturing problems.

Link FDA Warning Letter to Stryker

First Post-FDA Approved Stryker Cormet™ Hip Resurfacing Procedure Performed

Link  http://www.ryortho.com/NEWSSHORTS/volume3/issue35/11-07-07-NS-First.htm

By Walter Eisner November 7, 2007

Orville Todd is the first person in the U.S. to undergo Stryker's Cormet Hip Resurfacing procedure since the FDA approved the procedure last summer.

The procedure was performed by Richard A. Conn, M.D., an orthopedic surgeon with Southern Bone & Joint Specialists in Hattiesburg, Mississippi.

Todd, 60, said, “I had hip pain for about five years, and it just kept getting worse. Finally it got to the point where I couldn't stand it anymore. It made my job difficult—the longer the day went, the more I'd hurt." Since the surgery, Todd says, "I can do most anything now. Knowing what I know now, I would have gone in for this three years ago. It seems like it's going to be a long-term solution for me."

Hip resurfacing gives the more than 43 million Americans suffering from arthritis an alternative to total hip replacement.

Since performing the first procedure with the Cormet Hip Resurfacing System, Dr. Conn has used the system on an additional 10 patients. “Our patients’ results have been really strong, which makes for very satisfied patients and a very pleased physician,” said Conn. Dr. Conn trained with the surgeons who designed the Cormet Hip Resurfacing System in England, and he is a member of the surgeon-training group for the Cormet Hip, having trained more than 40 physicians from across the country on how to select the appropriate patient for this procedure and how to perform the procedure.

Stryker is the first company to give Smith & Nephew's Birmingham Hip™ Resurfacing System some competition in the U.S. marketplace. The other hip device manufacturers are also in the process of trying to get their own resurfacing systems through the FDA approval process.

Dr. Conn’s website states that he is compensated as a consultant for Stryker Corp. for the following areas:

Involvement in the design and development of a new partial knee replacement.
Participation in the training of orthopedic surgeons throughout the country for the Stryker Cormet Hip Resurfacing System.
Development of operating room efficiencies for surgeons and hospitals.

Birmingham Hip gets rival in resurfacing

 

Smith & Nephew monopoly lost; FDA approves device from Britain

 

By Daniel Connolly July 18, 2007

 

The Birmingham Hip implant by British medical device maker Smith & Nephew was the first hip resurfacing product to go on sale in the United States and has helped drive revenue at the firm's Memphis-based orthopedic units.

 

But a recent federal decision means the company will now face a rival in the fast-growing hip resurfacing market.

 

Earlier this month, the Food and Drug Administration approved the Cormet 2000 hip resurfacing device from British firm Corin Group PLC. An FDA panel had recommended approval in February. Stryker Corp. of Kalamazoo, Mich., plans to distribute the devices in the United States later this year.

 

When the hip goes on the market, it will break the American monopoly that the Birmingham Hip has enjoyed since its FDA approval in May 2006. Currently, it's the only product available in the United States for hip resurfacing, a relatively new surgical procedure used as an alternative to traditional hip replacement.

 

Both techniques are used in patients who have osteoarthritis and other joint diseases that cause pain and limit mobility.

 

Proponents of hip resurfacing say it destroys less bone than standard hip replacement surgery and is better suited for younger patients who want to maintain an active lifestyle. However, some surgeons have expressed concerns about results, including about a higher-than average early failure rate.

 

Smith & Nephew representatives have said the product is safe and effective, and the Birmingham Hip has been a sales winner for the firm.

 

In the first quarter, for instance, sales of the Birmingham Hip helped increase revenue in the firm's orthopedic reconstruction unit 15 percent to $262 million.

 

A Stryker spokesman declined to comment on competition with Smith & Nephew.

 

Brian Austin, vice president and general manager of Smith & Nephew's hip division, expressed confidence.

 

"We are realizing tremendous growth, particularly in the U.S.," he said in a statement. "We have been aware of Stryker's possible entry into hip resurfacing and are ready. ... We have a world-class training program and have already trained close to 1,000 U.S. surgeons. We are continuing to exceed our growth goals and fully intend to keep our market leading position."

 

-- Daniel Connolly

 

Smith & Nephew

 

World headquarters : London.

 

Worldwide employees : More than 8,500.

 

Local headquarters : 1450 Brooks Road.

 

Local employees : About 1,800.

 

Local presidents : Mark Augusti, president, trauma and clinical therapies division; Joseph DeVivo, president for orthopedic reconstruction.

 

Web site : Smith-Nephew.com.

 

READ COMPLETE ARTICLE

 

F.D.A. Approves Corin's Cormet Implant

 

F.D.A. Approves a Hip Resurfacing ImplantBy BARNABY J. FEDER Published: July 4, 2007 The regulator approved Corin’s Corment implant, bringing competition to the increasingly common procedure.

 

Hip resurfacing, a popular alternative implant to total hip replacement for younger patients disabled by hip failure, is about to become competitive.

 

The Corin Group of Britain and Stryker said yesterday that the Food and Drug Administration had approved the Cormet hip resurfacing implant by Corin, thus giving American consumers an alternative to Smith & Nephew’s Birmingham hip resurfacing system for the first time since the F.D.A. approved that device in May 2006.

 

Stryker, based in Kalamazoo, Mich., has a 10-year distribution agreement with Corin covering sales of the device in the United States. Stryker said that it hoped to have enough orthopedic surgeons complete the training program agreed upon with regulators to begin marketing the Cormet by the end of September.

 

Although total hip replacement has become a common and exceedingly successful operation for patients whose natural hip has been irreparably damaged by illness or injury, resurfacing has attracted surgeons and many patients because it preserves more of a patient’s thigh bone. That makes it easier to replace the original implant with a total hip in the future if necessary, which is often the case for active patients who have their artificial hips for 15 or 20 years.

 

Some hip resurfacing advocates say the procedure also leads to quicker recoveries, greater range of motion in the hip and a more natural distribution of weight and pressure on the thigh bone, or femur.

 

Skeptics say that much is still unknown about the long-term safety and durability of the resurfacing devices compared with the total hips and that most patients, particularly those older than 65, should stick with the older technology.

 

Analysts have forecast that 10 percent to 15 percent of the nearly 300,000 Americans a year who get hip replacements might be good candidates for resurfacing. Both operations cost $25,000 or more at most hospitals that offer them.

 

The F.D.A. action came more or less when Wall Street had forecast, based on the support for the device by the F.D.A. panel that reviewed clinical trial results in February. About 8 percent of the 302 resurfacing patients in the trial needed revision surgery within two years, a figure that the panel and the companies agreed highlighted the importance of carefully training doctors to identify which patients were most likely to have good outcomes.

 

The approval was announced after trading ended on Wall Street yesterday. Shares of Stryker, which are up more than 16 percent this year, rose 49 cents, to $63.95. Shares of Corin rose 1.64 percent, to 559 pence, on the London Stock Exchange.

 

READ COMPLETE ARTICLE

 

UPDATE 1-US experts support Corin hip device with conditions

 

New York (Reuters Health)