Device Manufacturers Increasing Focus on Women’s Health Market

Gender-based medicine isn’t a new practice in the medical community—the 1990s were even a decade of women’s health innovation, thanks to former President Clinton’s focus on these initiatives while in office. However, medical device manufacturers appear to be stepping up their efforts toward gaining market share in the lucrative women’s health market, if recent developments are any indication.

Orthopedic device giant Zimmer Holdings received FDA approval in May for its artificial “Gender Solutions” knee that was designed specifically for women. This replacement part was designed with attention to shape and details that focus on generally feeling more natural in women, who receive nearly two thirds of the 400,000 annual knee implants, according to the National Center for Health Statistics.

Research shows that while both women and men vastly under-use knee replacement, women are three times less likely than men to undergo the procedure, although they suffer from more knee pain and resulting disability. “Now that we have a knee shaped to fit women’s anatomy, we expect far more women will want to consider knee replacement,” said Dr. Robert E. Booth, MD, chief of orthopaedic surgery at Pennsylvania Hospital as well as one of Zimmer’s developers of the product.

Zimmer rival Stryker Corp., based in Kalamazoo, MI, has also ramped up its marketing toward women. The company’s Triathlon knee, which is available for both genders, has been implanted in approximately 30,000 patients, 60% of whom are women.

On a broader scope, Cook Inc., a medical device manufacturer in Indianapolis, IN, announced it would launch a new women’s health division that will focus on products that enhance quality of life for everyone from adolescents to women who are past menopause.

The company, which already markets devices for the high-risk obstetrics and fertility treatment markets, is expected to launch by the end of this year more products for biopsy, postpartum bleeding and pelvic organ prolapse surgery.

“Men and women are different and gender-based medicine is extremely important these days,” said Christina Anne, global leader of Cook Women’s Health, which will be based in Bloomington, IN. “Women are not just small men and we can’t just get the same treatment as men do because we’re very different.”

Respironics Announces Class I Recall of Ventilators

Murrysville, PA-based Respironics, Inc. announced the voluntary global recall of all of its PLV Continuum Ventilators after learning the product may suddenly stop providing mechanical ventilation, which could result in serious injury or death. The company identified the problem after an analysis of returned units revealed the potential for failure of an internal flow valve.

In course with this class I recall, involving 269 ventilators of all models and serial numbers, Respironics indicated that the recalled items should not be used until the problem is corrected. The company also noted that if a customer does not have a suitable substitute ventilator, Respironics will loan a comparable unit.

The PLV Continuum Ventilator is used to provide mechanical ventilation for pediatric and adult patients weighing at least 11 lbs. The device is intended for use at home, in an institution or as a portable ventilator. The recalled products have been distributed in the United States, Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia and Taiwan.

Originally announced in a letter to distributors, sales personnel and customers in March, Respironics reported it is continuing to contact customers to arrange for the return of all the recalled ventilators. No reports of adverse events or injuries related to use of these devices have been received to date.

Thermo Electron to Acquire Fisher Scientific

Waltham, MA-based Thermo Electron Corp., a medical instrument manufacturer, announced it will acquire rival Fisher Scientific International, based in Hampton, NH, for $10.6 billion. The transaction is expected to close in the fourth quarter of 2006, company executives reported.

The merger of these companies will form a new company named Thermo Fisher Scientific Inc., which is expected to have 2007 revenues of $9 billion and cash flow of $1 billion. The combination of the two companies will have 30,000 employees and a stock market value of approximately $15.5 billion, according to reports.

Fisher, which was founded in 1902 and markets more than 600,000 different products and services, had total sales of $5.6 billion last year; Thermo Electron had revenue last year of $2.6 billion. Both companies have been acquiring smaller companies in the last year, including Thermo’s nearly $1 billion acquisition last year of SPX Corp.’s Kendro Laboratory Products, a maker of centrifuges and other laboratory equipment.

“This combination brings together two well-respected industry leaders in the life, laboratory and health sciences marketplace to create a company that has the product breadth, global reach and operational expertise to drive significant value for shareholders, customers and employees,” said Marijn E. Dekkers, president and CEO of Thermo, who will become president and CEO of the combined company. “By combining our companies’ complementary world-class product and service offerings with Fisher’s unparalleled customer access, we expect to accelerate growth by further penetrating our vast customer base.”

Sterilization Executives Convicted After Selling Unapproved Devices

Two executives of AbTox, based in Mundelein, IL, were convicted of fraudulently selling uncleared surgical sterilizing devices that led to eye damage in 18 patients, causing them to lose sight in one eye.

Former AbTox President and CEO Ross Caputo and VP of Regulatory Affairs Robert Riley were convicted after marketing an unauthorized version of an FDA-approved small gas plasma sterilizer that was indicated for use in sterilizing flat stainless-steel surgical instruments. The larger, unapproved sterilizer was illegally being promoted for use in various complex, non-stainless-steel instruments.

One unauthorized use was to sterilize ophthalmic instruments that had brass joints, which reacted to the sterilizing agent, creating a toxic residue. AbTox knew of the reaction but did not advise users or seek proper corrective action.

AbTox had shown the hospitals, which purchased 168 of the larger unauthorized units, the FDA’s clearance letter for the smaller, authorized unit. Sales of the unauthorized units totaled more than $18 million.  

After several hospitals reported to AbTox that their sterilizer was suspected of causing injuries to several patients, the company did not notify the FDA about these reports as required.

“These convictions are evidence of FDA’s resolve to ensure the safety and efficacy of human medical devices. Our criminal investigators aggressively pursue those that endanger the public health by manufacturing and selling unsafe products,” said Margaret O’K. Glavin, FDA’s associate commissioner for regulatory affairs.

The defendants were convicted of three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device and conspiracy to defraud the FDA. Riley was also convicted of one count of making a false statement for lying to the FDA. The defendants face significant penalties including incarceration, fines and restitution. Two other defendants from AbTox, former director of marketing Mark E. Schmitt and former director of clinical services Marilyn M. Lynch, previously pled guilty in this case.