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The American Academy of Orthopaedic Surgeons (AAOS) has created an independent, nonprofit organization that is dedicated to monitoring the performance of knee and hip replacement procedures. The American Joint Replacement Registry (AJRR), which cost about $20 to $25 million to initiate, will be funded by stakeholders that include surgeons, hospitals, and device manufacturers. By monitoring device performance, the registry will provide information about underperforming processes or devices and as a result, could lead to healthcare savings. AAOS’ fact sheet about AJRR is available here.

Johnson & Johnson’s Ethicon EndoSurgery has reached a deal with the University of Texas (UT) at Arlington and UT Southwestern Medical Center to provide funding that will enable the development of surgical instruments. The centers are working on magnetically-controlled instruments, specifically for abdominal surgeries. The magnetic technology enables surgeons to maneuver inside the abdomen without making invasive incisions. Dennis Stone, MD, vice president of technology at UT Southwestern, indicates that the technology will initially be useful in gallbladder surgeries, but the goal is for the surgical instruments to be applied across several areas.

Boston Scientific, Medtronic, St. Jude Medical, and Endoscopic Technologies are among the companies named in whistleblower lawsuits alleging they promoted surgical devices for off-label uses. The suits were filed under the False Claims Act and alleged that the off-label marketing resulted in excessive Medicare reimbursements. Endoscopic Technologies agreed to pay the United States $1.4 million to settle the lawsuit related to the promotion of its surgical ablation devices. The government stated that the company also promoted expensive heart surgery using its devices when other less invasive alternatives were appropriate. It also alleged that Endoscopic Technologies gave kickbacks to healthcare providers to use its devices.

Researchers at the University of Florida (UFL; Gainesville) have developed a surgical device that helps eliminate the frustration surgeons face in tying knots. The use of the knotless fastener provides advantages especially in minimally invasive, laparoscopic procedures in which surgeons are working with small instruments. The fastener avoids damaging tissue, because it distributes tension across tissue rather than concentrating on one area, and thus reduces the need for additional surgeries. It also has use in circumstances when a surgeon must stretch tissue to close a gap caused by lost or displaced tissue. UFL is looking for companies that are interested in commercializing the device. For more information, contact the university’s Office of Technology Licensing.

Using nanostructured biomaterials, Nanovis Inc. has begun initial testing on its bone regeneration technology. Jointly developed by Nanovis, Purdue University, and Brown University, the tissue technology promotes bone growth in patients who have a high risk of bone fracture. Nanovis expects a commercial launch within three to five years. The premise of the technology was developed when researchers found that tissue implants engineered with nanoscale coatings were more likely to incorporate into existing tissue than standard implants, leading to the growth of new tissue, stronger bones, and less inflammation.

The company is based at Purdue Research Park (West Lafayette, IN). Indiana’s 21st Century Research and Technology Fund has provided a grant for Nanovis to conduct the testing of its product. It is also developing other nanosurface technology for orthopedic, spinal, cardiovascular, and soft tissue implants for hernia and bladder repair.

ConforMIS Inc. (Burlington, MA) has reached a milestone that will enable the company to continue building its infrastructure and roll out a new total knee resurfacing system. In its largest equity round to date, the company has raised $50 million in U.S. and international funding. ConforMIS CEO Philipp Lang, MD, says it will be focusing efforts on preparing for the launch of the iTotal system, which he anticipates will be the company’s biggest product yet.

“It’s not so much that [the funding is] enabling us to do some things that we previously hadn’t planned on doing, but it’s a way of supporting the strategy that we’ve had in place for some time in a full way,” says Jong Lee, senior vice president for strategy at ConforMIS. “It allows us to continue to operate soundly and viably and to introduce iterations of existing products, along with going after the iTotal.” Lang is aiming for a early 2010 product launch.

The company is also looking to expand outside of the knee. It currently has more than 250 patents filed, which Lang says can be applied to hip and shoulder joints, ankles, and wrists. The strategy remains to spare as much bone and tissue as possible to enable more future options for patients. “The single most precious tissue in orthopedic surgery is bone, and it’s key to preserve as much bone as possible and if you can, cartilage,” says Lang. “We’re following that objective and rationale as we deploy more implants in the knee, and in the future, into other joints.”

ConforMIS’ personalized options also put the company in a unique position in the $20 billion orthopedics market. As the rest of the year plays out, the company will continue to aggressively build its direct sales force and leverage its sales team by staying within the total knee space.

And although the recession has done its damage to the industry, Lang says his company hasn’t felt the negative effects. “I think the investor community has clearly recognized that if you come up with a highly innovative and disruptive technology into one of those existing markets, there’s potential for very significant returns, even in a difficult external economic environment,” he says. “At the bottom line, when you look at the fundraise that we completed, it shows there’s continued strong interest by some of these large crossover investors and global investors in innovative technology.”

The publisher of Med-Tech Precision, Canon Communications LLC( Los Angeles), is launching two events next year for the orthopedics manufacturing industry. The OrthoTech Conference & Expo will be held in Warsaw, IN, the U.S. hotbed for orthopedics companies on May 12-13, 2010. The industry event will feature 70 suppliers that provide a range of services, from surface modification and coatings to a variety of precision machining processes. The European event, OrthoTec EU, will be held in Switzerland from September 29-30, 2010.

According to Kevin O’Keefe, senior vice president of Canon’s events division, both events will “focus on design and collaborative product development between leading orthopedic surgeons and R&D directors from the largest orthopedic device manufacturers, as well as technical sessions on manufacturing and quality practices.”

The announcement of the orthopedic shows comes at a time when the industry is expected to continue on its steady path of growth, despite current economic conditions.“The strong growth of the orthopaedic sector, and for that matter the entire medical device market, comes as no surprise considering the demand statistics,” said Charles McCurdy, CEO of Canon, in a company statement. “For example, 41% of all Americans are now over the age of 45, and in the EU people over 65 years old number more than 90 million. Companies supplying products and services for the orthopaedic sector and the overall medical device manufacturing market certainly have bright prospects.”

Certain arthroscopic shavers are retaining pieces of tissue after being cleaned, which compromises the sterilization process, according to an FDA alert. The agency indicated that based on the reports it has received, the tissue that remained in the devices wasn’t obvious to the naked eye. In addition to following the proper procedures for cleaning and sterilizing these devices according to the manufacturer’s instructions, FDA is recommending that facilities inspect the inside of the shavers after cleaning. The facility that alerted FDA to the issue uses a 3-mm video scope to inspect the channels of the device hand piece.

Manufacturers that find retained tissue in the shavers following cleaning can get information about how to file a voluntary report with MedWatch here.

Medtronic Inc. intends to lay off more than 50 people from its Spinal and Biologics division, according to Memphis-based The Daily News. The reduction is part of a streamlining effort that was announced in May in which the company stated its intent to reduce its global staff from 1800 to 1500. Last year, Medtronic cut more than 1000 jobs, but this most recent cut shouldn’t come as a surprise. In February, CEO Bill Hawkins stated that the company would plan on making cuts in its new fiscal year. At that time, company executives also took a 5% pay cut.

Despite the anticipated lay-offs, the Memphis division saw a 14% increase in annual revenue ($3.4 billion) at the end of its fiscal year. This is attributed to Kyphon’s $609 million in sales.