Zimmer Holdings Inc. claims the position as the largest provider of reconstructive orthopedic devices in China. The Warsaw, Ind.-based firm has acquired Beijing Montagne Medical Device Co. Ltd. in an effort to expand its footprint in the growing Asian implant market.
Montagne’s product lines will provide an expanded product line in hips, knees and powered surgical instruments that are “tailored to the Chinese market,” according to an announcement from Zimmer. “We want to create products that address the unique needs of the Chinese market. Montagne will provide us access to additional research, development, and manufacturing capabilities that will allow us to achieve this goal,” said Stephen Ooi, president of Zimmer’s Asia Pacific division.
Montagne has two plants, one in Beijing and one in Xianning, Hubei—both of which are certified to ISO 13485:2003 and ISO 9000:2001 quality standards. The company employs 360 people, according to its website. Zimmer’s sales in the Asia Pacific market steadily have been rising over the last several years, going from an annual total of $469 million in 2005 to $604 million last year (the region’s 2009 proceeds accounted for 15 percent of the $4.1 billion in sales Zimmer reported that year). Countries within the Asia Pacific market include Australia, China, India, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan and Thailand. (Hong Kong also is considered part of the Asia Pacific market even though it technically is a city.)
The sales surge continued in the third quarter of 2010, with Zimmer reporting increases in the region’s overall sales as well as those of artificial hips, knees and extremities. Asia Pacific sales amounted to $166 million, a 12 percent jump compared with the $148.7 million the region amassed for the company in the third quarter of 2009. Knee sales rose 9 percent, going from $57.3 million in the third quarter of 2009 to $62.2 million in the same period of 2010. Hip sales swelled 12 percent, going from $50.7 million in Q3 of 2009 to $56.9 million in 2010, while sales of extremities soared 18 percent, going from $2 million in Q3 of 2009 to $2.4 million in 2010.
Just days after the announcement about China, the company finalized a deal for Sodem Diffusion S.A., the manufacturer of SoPlus Orthopaedic Surgical Power Tools based in Geneva, Switzerland. The company will be renamed Zimmer Surgical S.A. and will be part of Zimmer Surgical, headquartered in Dover, Ohio. Deal details were not disclosed.
“Adding SoPlus’s innovative small and large bone product lines to our portfolio will expand our offerings in the orthopaedic power equipment market,” said Mark Dorris, president, Zimmer Surgical.
This acquisition will broaden Zimmer’s portfolio of surgical power tools and strengthen the company’s position in the more than $1 billion surgical power tool market. Sodem Diffusion’s portfolio includes the commercially available SoPlus Universal large bone system and the SoPlus Ultra small bone system with associated consumables.
In addition, Zimmer recently launched its NexGen LPS-Flex Mobile Bearing Knee with Prolong highly crosslinked polyethylene (XLPE) in the United States.
According to Zimmer officials, the new implant provides a “revolutionary” anteriorly positioned pivot near the entry point of the anterior cruciate ligament, replicating the anatomic center of knee rotation.
The LPS-Flex Mobile system is backed by more than ten years of clinical history in Europe and Japan. Since the system’s launch, more than 130,000 LPS-Flex Mobile knees have been implanted worldwide.
“Our Prolong highly crosslinked polyethylene provides a number of clinical advantages, including reduced wear and delamination resistance,” said Jeffrey A. McCaulley, president of Zimmer’s reconstruction division.” Applying this exciting material to our NexGen LPS-Flex Mobile Bearing Knee System represents a major step forward in mobile bearing design.”
According to McCaulley, the firm’s testing showed that the LPS-Flex Mobile with Prolong Polyethylene system demonstrated an 83 percent wear reduction compared to conventional polyethylene.
Zimmer was the first company to launch XLPE more than nine years ago for the NexGen Fixed Bearing system. Since its launch, the blend specifically formulated for the knee has been used in more than 450,000 implantations worldwide.
MDT Gets CE Mark forCervical Fusion Device
Medtronic Inc.’s Spinal and Biological division is ringing in the new year with a new product launch overseas. The medical device manufacturer has begun selling the PEEK Prevail Cervical Interbody device in Europe, where an estimated 60,000 cervical fusion procedures are performed annually.
The device—which received 510(k) approval from the U.S. Food and Drug Administration in May 2008—is used to treat patients with diseased cervical discs (found in the neck). Such diseased discs often lose height, compressing the nerves and causing pain in the neck area and arms. Medtronic’s PEEK Prevail device is designed to provide stability when surgeons fuse (join) two vertebrae together in an effort to relieve the compression on the spinal cord or nerve roots.
Bone grafts can be used to restore disc height; surgeons traditionally have covered the graft with a metal plate anchored to the spine with four screws to provide stability and prevent the graft from moving. The zero-profile PEEK Prevail device eliminates the need for a plate and attaches to the spine using only two screws, according to Medtronic.
With two integrated bone screws, the PEEK Prevail product provides the same kind of rigidity found in such traditional techniques of a threaded cage or a graft with plating, biomechanical data show.
Made of polyetheretherketone (PEEK), the new implant is invisible on X-rays, a characteristic that enables surgeons to see the spinal fusion at follow-up visits. Featuring an “I-beam” shape with a two-screw configuration, the device incorporates a nitinol wire locking mechanism to keep the screws securely in place.
“With the PEEK Prevail Cage, you can achieve a solid fusion,” said Eric Put, M.D., a neurosurgeon at the Jessa Hospital in Hasselt, Belgium. “When using this cage additional plating is not necessary. As this cage is easy to implant, surgery time and traction on the oesophagus is significantly reduced. I believe this is a safe and reliable cervical cage, which may contribute to a better outcome for our patients.”
The PEEK Prevail device is designed for patients suffering from cervical disc disease from the C2-C3 disc to the C7-T1 disc. The product must be used with internal screw fixation provided by ZEPHIR Anterior Cervical screws, according to Medtronic.
The PEEK Prevail device is used with an autograft and is implanted through an anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Medtronic’s Spinal and Biologics business is based in Memphis, Tenn., and operates its Kyphon unit’s balloon kyphoplasty, IPD and diagnostics business in Sunnyvale, Calif., and Brussels, Belgium.
Boston Sci Closes Neurovascular Division Sale to Stryker Corp.
On Jan. 3, Boston Scientific Corp. completed the previously announced sale of its neurovascular business to Stryker Corp. In addition, the company also prepaid $600 million in senior notes that were due June 1. There will be a pretax charge of $15 million in the fourth quarter for accelerated interest expense on the prepayment,officials said.
The neurovascular business is based in Fremont, Calif., and makes devices that are used to treat brain aneurysms and other vascular diseases that affect the brain. Its products include stents and detachable coils. Stryker and Boston Scientific announced the deal in late November.
Boston Scientific said Stryker paid $1.38 billion upfront for the business, along with a $50 million milestone payment. Another $24 million was placed in escrow and will be released when the deal closes in foreign markets. Stryker will pay the last $50 million when some manufacturing facilities are transferred or separated from Boston Scientific.
The Natick, Mass.-based device firm has begun to reshape its product offering in the face of slower sales for its primary heart stents and implantable defibrillators businesses. Kalamazoo, Mich.-based Stryker also is pursuing faster-growth opportunities after sales of its hip and knee replacement joints slowed in the recession.
The company is focused on paying down a large debt load it accumulated in the 2006 acquisition of Guidant Corp. It also plans to record a pretax gain from the sale of the neurovascular business of more than $500 million in the first quarter. Profit for 2011 would be reduced by about 4 to 6 cents, according to Boston Scientific. Stryker said the deal will be neutral to its profit in 2011 or could increase it slightly. That estimate excludes one-time charges.
Women Have Hip Revisions More Frequently Than Men, Study Claims
Women are more likely than men to undergo a second hip replacement, particularly after receiving an implant made by DePuy Orthopaedics Inc., according to data from the National Joint Registry of England and Wales.
Twelve percent of patients with DePuy’s hip resurfacing system and 13 percent of those with the firm’s acetabular system needed corrective surgery, the data showed. And, there is proof that a patient’s hip size can determine the frequency of revision surgery: A study conducted by the University of Adelaide in Australia concluded that the risk of revision is highest in patients with ASR femoral head sizes below 50 millimeters in diameter. Such sizes affect mostly female patients.
Joint replacement registries in both Australia and the United Kingdom have recorded higher than expected complications with DePuy’s ASR Hip Resurfacing System and ASR XL Acetabular System total hip replacement, including a loosening of the implant within the body, bone fractures near the implant, dislocation and a condition called metallosis, which occurs from the rubbing of metal parts.
The growing number of patients needing a second hip replacement prompted Johnson & Johnson’s DePuy Orthopaedics unit to recall its ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur in order to preserve more bone. The company announced the recall on Aug. 26 last year.
About 93,000 ASR devices have been implanted in patients worldwide, according to DePuy. And while the recall may have come as a surprise to some patients, experts have claimed it was inevitable, saying failure rates and patient complaints doomed the device. Over the last two years, the FDA has received about 400 complaints from American patients who received the implants, according to a March 2010 article in The New York Times.
In late 2009, DePuy said it was phasing out the implants due to slowing sales. Last March, the company warned doctors that the implants might have a high failure rate in some patients. In a letter dated March 6, 2010, DePuy told doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patients. The letter said the data shows that the risk is highest for patients of small stature, a group that typically includes women, and patients with weak bones.
Many hospitals that specialize in joint replacement surgery had already noticed a higher failure rate with the DePuy hip implants, Joshua J. Jacobs, M.D., chairman of orthopedic surgery at Rush University Medical Center in Chicago, told the Times. “Most major medical centers have seen issues with this device. This does not come as a surprise,” he told the newspaper.
Stryker’s Bone Growth Division Sold to Olympus Corp.
Stryker Corp. has inked a deal to sell its bone growth product franchise—the OP-1 product line—to the Olympus Corporation for $60 million. The product line was manufactured by Stryker’s Hopkinton, Mass.-based subsidiary Stryker Biotech LLC. The deal also includes the divestiture of the Kalamazoo, Mich.-based orthopedic giant’s manufacturing plant in Lebanon, N.H. The transaction has been cleared by the boards of both companies.
The OP-1 product line includes OP-1 Implant and OP-1 Putty for use in orthopedic bone applications such as lumbar spine fusion and the treatment of long bone fractures. The active ingredient in these products is the OP-1 bone growth factor that induces the formation of new bone when implanted.
OP-1 products currently are approved in the United States by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE), having provided treatment to roughly 40,000 patients globally. The HDE allows a medical device to be marketed whose effectiveness has not been fully proven and is intended to benefit patients with a rare disease or condition that afflict fewer than 4,000 U.S. patients annually.
In August, the company settled a lawsuit filed against its biotech division by the Massachusetts attorney general accusing it of illegally promoting the combination of a pair of its OP-1 products not approved by the FDA. Stryker paid $1.35 million to settle the suit.
With the sale of OP-1, Stryker officials said they plan to redirect a part of the related R&D spending to other internal projects, which they believe have the potential to deliver better returns.
New Bioskills Lab for Paragon Medical
Paragon Medical has opened its new Bioskills Lab at the firm’s headquarters in Pierceton, Ind. Company management and employees were joined by the Warsaw/ Kosciusko Chamber of Commerce and other local officials at a ribbon cutting on Jan. 19. In December 2009, Paragon announced that through its Orthopaedic Instrument Global Design Center (OIGDC), it would accelerate the construction of this new lab in direct support of OrthoWorx, a Warsaw, Ind.-based industry, community and education initiative established to advance and support growth and innovation within the region’s globally significant orthopedics device sector. The fully staffed facility is ready for client scheduling and includes capacity for up to four cadaveric evaluation stations and targets the comfort of lab attendees through ergonomic tables, laminar airflow, separate temperature zones, and a private conference room with a viewing window into the lab, the company said.Other services will include specimen procurement and preparation, instrument cleanup, C-arm and arthroscopy tower rentals, audio-visual connectivity, and full catering capabilities.
According to Van Flamion, director of the Bioskills Lab and Paragon’s OIGDC, the lab was designed to provide Paragon’s customers a “convenient, cost effective, full-service facility where orthopedic and other medical device companies can perform cadaveric studies on their products and/or train their surgeons or field representatives on surgical techniques pertaining to their products.”
Paragon Medical supplies custom and standard cases and trays, as well as surgical instrumentation, implantable components, and design services to the medical device industry. — ODT Staff