Medical Device Link.

Artificial Leg Makes Automatic Adjustments

A leading prosthetic manufacturer has unveiled what it calls the world's first artificial leg controlled completely by a computer.

The C-LEG from Otto Bock Orthopedic Industry (Minneapolis) features the same advanced technology used by the military to improve the performance and stability of its aircraft. This technology automatically adjusts to the amputee's movements, immediately adapting to different walking speeds and providing stability when needed.

The C-LEG's electronic sensors monitor leg and knee position 50 times per second. Data collected by the sensors are sent to a hydraulic damper that controls stance and swing-phase movements. Added hydraulic stance stability is supposed to prevent unintentional knee bending that sometimes occurs on uneven terrain.

Microprocessor control of the C-LEG is based on scientific gait analyses and biomechanical studies. With computer technology monitoring and controlling each step, the leg lets lower-limb amputees walk down steps and engage in other physical activities with a high level of confidence. "I've worn 10 artificial legs in the past 30 years, and the C-LEG is miles ahead of anything that I've experienced," says Mark Marich, a Rhode Island prosthetist and amputee who was recently fitted with the device.

"The C-LEG knows where you are at all times," adds Mike Tallman, an Albany, NY, amputee who also wears the new prosthesis. "It measures real minute movements and makes adjustments based on the environment. It's like having a specialist behind you adjusting the hydraulic tension of the unit with each step."

Molded Plastics Replace Metal in Testing Equipment

The metal parts that are traditionally used in gynecological applications have several drawbacks that affect both doctor and patient. For example, they must be sterilized after each use, and their cold temperature can cause patient discomfort.

Endeavoring to eliminate these drawbacks, Welch-Allyn Corp. (Skaneateles Falls, NY) opted to mold high-volume, disposable parts using Polifil, a 10% talc-filled polypropylene from The Plastics Group of America (Woonsocket, RI). Designed for a device used in Pap smear testing, the tight-tolerance parts are made with a 16-cavity valve-gated hot runner, which can produce parts in large quantities. The parts feature two ratchets built into the yoke for adjustment and release of the product. Molded-in teeth on one part of the yoke work together with a ratchet to open and close separately molded acrylic blades, which play a role in gynecological examinations.

Sales of the Welch-Allyn product have soared in recent years, according to Neil Hoselton, the company's commodity manager of plastics. "We see a trend toward the use of single-use, disposable parts in the medical industry," he says.

For more information about Polifil polypropylene, call The Plastics Group of America at 401/767-2700.

'Titans' Dominate Medical Industry, Analyst Says

A handful of large-capitalization companies—the "titans"—are dominating the medical product field and are poised to improve their position in the coming years, according to a research analyst who studies the medical market.

The major players—including Johnson & Johnson, Abbott Laboratories, Boston Scientific Corp., Medtronic Inc., Guidant Corp., and St. Jude Medical Inc.—are in commanding positions in the largest medical market segment, consisting of products that treat cardiovascular conditions. In addition, these companies are poised to take leadership roles in other fields by offering new products to treat neurological and peripheral vascular diseases and disorders, according to Kurt Kruger, medical products analyst for Banc of America Securities LLC, a subsidiary of Bank of America Corp.

Kruger also notes that, instead of a "clash of the titans," the healthcare industry may have to deal with a "club of the titans," an oligopoly of very few companies that set up high entry barriers in the fields they dominate. With sales of $1 billion or more, top-line growth of more than 10%, and operating profitability of more than 15%, these companies should grow increasingly powerful and seize control of an ever-larger share of the medical products market, Kruger predicts.

Since cardiovascular disease is the leading cause of death in the United States, Kruger sees good times ahead for manufacturers of cardiovascular devices. For example, he predicts that total revenue from stent sales will increase 6% in 2000 and 4% in 2001, bringing stent revenues to $3.5 billion.

Coatings Could Lengthen Life of Joint Replacements

Each year, more than 500,000 total and partial joint replacement procedures are performed in the United States, and the number will be increasing due to an aging population. Therefore, products that reduce artificial joint wear and failure could have far-reaching human and economic consequences.

With the support of the federal government, Spire Corp. (Bedford, MA) will be trying to come up with two such products. The company has received a pair of grants totaling $200,000 from the National Institutes of Health (NIH) to develop processes that would lead to significantly increased life spans for hip and knee orthopedic prostheses. If the project's initial phase results are encouraging, Spire will be eligible for an additional $1.7 million from the NIH.

Under the terms of the grants, Spire will develop coatings to reduce wear and increase the life span of two important materials used in orthopedic prostheses: ultrahigh molecular weight polyethylene (UHMWPE) and cobalt-chrome metal. UHMWPE will be coated at room temperature with a super-hard biocompatible ceramic coating that has excellent adhesion and low surface friction. The cobalt-chrome component will be treated with a metal matrix composite that will combine the best wear characteristics of ceramics and metals. Both coatings use Spire's proprietary ion beam deposition process.

For more information, contact Spire at 781/275-6000.

In Brief

Johnson & Johnson (New Brunswick, NJ), a worldwide manufacturer of healthcare products, has completed its $4.9 billion merger with Centocor Inc. (Malvern, PA), a manufacturer of vascular care and immunology products...Sybron International Corp. (Milwaukee), a laboratory and dental supply manufacturer, has completed the acquisition of Robbins Scientific Corp. (Sunnyvale, CA), a manufacturer of biomedical products...Tekni-Films (Somerville, NJ), a Tekni-Plex company, will start production in its new 90,000-sq-ft laminating and converting center in Aalst, Belgium, in the first quarter of 2000...Digital medical diagnostic technologies provider Brentwood Medical Products (Torrance, CA) has been named a winner in the Ambulatory Care—Clinical/Patient Information Systems category of the Microsoft Healthcare User's Group's third annual Industry Solution Awards for Healthcare...A joint venture has been announced between Uniroyal Chemical (Middlebury, CT) and Teknor Apex Co. (Pawtucket, RI) to develop and market thermoplastic vulcanizates...Zing-Pac Ltd. (Cleveland), a packaging and printing equipment manufacturer, has purchased the printing and packaging division of I.D. Images Inc. (Strongsville, OH)...A 500,000-sq-ft site in Salto, Brazil, will be the location of a plastic film and sheet manufacturing plant for Klöckner Pentaplast do Brasil Ltda., a subsidiary of Klöckner Pentaplast of America Inc. (Gordonsville, VA). The scheduled completion date for the first 85,000-sq-ft phase is January 2001...Angeion Corp. (Minneapolis), a manufacturer of implantable cardioverter defibrillators, has entered into a merger agreement with Medical Graphics Corp. (St. Paul, MN), which develops systems that diagnose and manage heart and lung disease. Angeion will acquire all of the outstanding shares of Medical Graphics for approximately $16.3 million...Bayer Corp., Diagnostics Division (Tarrytown, NY), has won a 1999 R&D 100 Award for its Rapidpoint 400 measurement cartridge in the 37th annual R&D Magazine awards competition. The fully automated point-of-care whole blood analysis system was recognized for providing laboratory-quality results within 60 seconds...MedAssets Exchange Inc. (Wood Dale, IL), a supplier of customized medical equipment, has acquired ReMedPar Inc. (Goodlettsville, TN), a diagnostic imaging parts supplier. The newly acquired company will keep its name and continue to operate out of its 66,000-sq-ft facility in Goodlettsville...E/M (Atlanta), a supplier of engineered coating services, has acquired P.T. Coatings Ltd. (Evesham, Worcs, England), which specializes in applying fluoropolymer and dry film lubricant coatings. P.T. Coatings will assume the name E/M Coatings Ltd.-UK...Acuson Corp. (Mountain View, CA), a manufacturer of diagnostic ultrasound systems, has signed a definitive agreement to acquire Ecton Inc. (Plymouth Meeting, PA) for stock valued at $23 million. Ecton, which will become the small systems division of Acuson, is developing a miniature, all-digital echocardiography platform.