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Jan
27

From clinical trials to regulatory hurdles to increasing competition in the market, there are so many pressures that medical device manufacturers face on a daily basis. Unfortunately, it often takes a catastrophic event to put things into perspective in both our personal and professional lives.

Less than 14 days ago, a devastating earthquake hit an already suffering Haiti, and help came pouring in from the military, missionaries, doctors, and medical device companies, just to name a few sources. Manufacturers of orthopedics, cardiovascular, and surgical products were among the many companies that have been doing their part.

Last week, DJO Inc. made its largest donation ever of medical products to Haiti. Medtronic Inc. pledged $1 million through the Medtronic foundation and will be matching employee donations up to $250,000. Surgical device manufacturer Abbott Labs has donated $2.5 million in grant funding and critical products. Henry Schein, supplier of a range of products, including surgical instruments and orthopedic products, sent supplies through a variety of organizations that included AmeriCares, Heart to Heart Cares, and International Medical Corps. As part of its $250,000 donation, Hanger Orthopedic Group Inc. has contributed $225,000 in devices such as neck and back braces, wrist splints, and cervical collars.

These are just a few examples of how device manufacturers are answering the call of a nation in need. How are you doing your part? Whether it’s making a donation or sending products, we want to hear about it. Tell us your story at mtpmagazine@cancom.com.

–From Med-Tech Precision’s e-newsletter. To subscribe, click here.

Jan
22

DJO Inc. (San Diego) made its largest ever donation of orthopedic medical products to help the earthquake victims in Haiti. Donated products included immobilizers and splints for the neck, shoulder, arm, wrist, knee, and ankle.

“All of us here at DJO have been deeply affected by the tragic events in Haiti. We are fortunate to be in a position to help and proud to step up and contribute to the relief effort there,” said Les Cross, president and CEO of DJO, in a company statement.

The donation was made to health and humanitarian aid organization Project HOPE.

Jan
21

Instruments of Mercy Inc., a nonprofit group that repairs medical instruments for missions around the world, is offering to repair all flexible endoscopes, rigid endoscopes, power equipment, stainless instruments, and laparoscopic and specialty instruments for surgeons and their teams helping earthquake victims in Haiti.

“We’ve heard reports of surgeons having to use rusty instruments and hacksaws to amputate limbs,” said Gene Robinson, the organization’s founder. “This is an important area where we think we can help.”

For more information, email Toney Peer at toneypeer@instrumentsofmercy.org or call 205/913-6032.

–From DeviceTalk

Jan
21

Tomorrow morning, ArthroCare Corp. (Austin) will begin trading shares of its common stock on the NASDAQ global market under the symbol ARTC. The manufacturer of minimally invasive surgical products received a delisting notice nearly one year ago. Following the suspension of trading, ArthroCare requested a review from the NASDAQ Listing and Hearing Review Council. During the past year, the company also restated its financial statements for 2006 and 2007 (audited), and 2004 and 2005 (unaudited). The restatement reduced ArthroCare’s revenue by 12%, 7%, 4%, and 1%, respectively.

As for its 2010 plans, Scott Schaffner has been named senior VP and general manager of the company’s sports medicine business, effective January 25. President and CEO David Fitzgerald says that the company will be introducing new technologies this year, as sports medicine remains the main focus of ArthroCare’s 2010 business strategy.

Jan
21

In addition to the aging population, the growth of future hip and knee replacements will be driven by a trend towards early surgical intervention in patients between 44 and 65 years old, according to a new market study. The U.S. hip and knee replacement market was worth $6.7 billion in 2008 and is expected to grow to $14.8 billion by 2015. The knee replacement market, which is the largest segment of the joint replacement market, is anticipated to achieve 12.9% growth and hit $9.6 billion in 2015. Other factors that will contribute to the growth of these markets include osteoarthritis, greater penetration of existing devices, and joint resurfacing procedures.

Orthopedics companies are targeting a younger patient demographic with products that feature improved materials that increase implant life and minimally invasive procedures that enable a faster recovery. The study also cites direct-to-consumer advertising as a means through which companies are promoting hip and knee replacements, because they are showing patients how they can maintain an active lifestyle as they age.

Jan
20

Private equity firm Riverside Partners (Boston) has announced a majority investment in CTW Inc. (Hernando, MS), an orthopedics contract manufacturer. The investment is on behalf of Tegra Medical, which is a portfolio company of Riverside. CTW is an outsourcing manufacturer that works with orthopedic companies in the areas of spine, trauma, knees, and hips. Its services include Swiss-style turning, multiaccess CNC milling, EDM, and laser processing. According to CTW President Dale Cole, the company will be able to continue its strong growth with the help of Riverside’s capital and resources, and Tegra Medical’s sales and marketing infrastructure.

Jan
20

Biomet Inc. is continuing its commitment to funding graduate medical education programs in orthopedic surgery by donating $1.4 million to orthopedic fellowship and resident enhancement programs. The funding is part of a partnership between Biomet and the Orthopaedic Research and Education Foundation (OREF). Fellowship funding will underwrite education in subspecialties that include adult reconstruction, oncology, trauma, and spine. Biomet made its first donation last year as part of a multiyear commitment. OREF receives and approves the grant requests, and the applications are reviewed by an independent panel of doctors who have no industry conflicts. In 2009, Biomet funded 31 of the 50 fellowship grants that were awarded by OREF.

Jan
19

In a study published in Developmental Cell, researchers from the Weizmann Institute of Science (Rehovot, Israel) explain how the relationship between tendons and bones are part of the assembly of the musculoskeletal system. Elazar Zelzer, PhD, and his colleagues began their research with the intention of finding the molecular mechanisms that regulate bone ridge formation. Bone ridges enable the skeleton to handle the mechanical stresses caused by muscles. The researchers found that the formation of bone ridges occurred as a result of an interaction between embryonic tendons and muscle activity. For the full text of this study, check out this link.

Jan
19

Mainstream media attention always helps put procedures in the spotlight, whether they’re completely new or doctors have been doing them for years. Yesterday, the New York Times suggested that ankle replacements could be the next up-and-coming surgical procedure in the joint replacement arena. One of the main reasons is the same trend that has applied to other joint replacements–aging baby boomers. Improvements to the devices have also helped the cause. Newer ankle replacements don’t require the removal of as much bone as previous devices, and surgeons have access to better instruments that are used for aligning the joint. Jonathan Deland, chief of foot and ankle service at the Hospital for Special Surgery (New York City), told the Times that 90% of newer ankle replacements were still in place after nearly 8.5 years. This is significant, because failure and loosening are among the biggest concerns with these devices. In addition, slow healing and infections are among the complications. It is estimated that 4400 patients will receive ankle replacements this year.

Jan
14

Early-stage company SpineAlign Medical Inc. (San Jose) has entered into a agreement with Italian distributor ab medica SpA (Milan) for its first CE mark-registered product. The minimally-invasive SpineAlign Vertebral Body Replacement (VBR) system is intended treat thoracic or lumbar spinal fractures in patients who have osteoporosis. Composed of a nickel titanium alloy, the expandable device has internal scaffolding that engages the vertebral body endplates and maintains lift during bone cement injection. The VBR system is currently undergoing clinical evaluation in the United States. The product received a CE mark in July.

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