Karl Storz HalfPipe allows easy placement

Given healthcare’s stringent fiscal and technological demands, arthroscopy equipment manufacturers are shouldering the burden of developing products that improve surgeon technique and patient outcomes, and offering them at a price that won’t bottom out most operating room budgets.

Despite the somewhat daunting task, vendors appear to be living up to – and even exceeding — those expectations. In fact, in many cases, manufacturers are making cutting-edge technology that once seemed reserved for the future available today.

"Arthroscopy has evolved to meet the changing needs of the population," explained John Konsin, vice president of marketing, Smith & Nephew Endoscopy, Andover, MA. "In interacting with surgeons, we recognized that to better meet those needs, we need to have innovative products that focus on specific techniques. Combining products with technique is the most effective way to improve outcomes."

To say the arthroscopic industry is experiencing an upswing is a gross understatement, both from an equipment manufacturer and healthcare provider perspective. Statistics show that approximately 28 million musculoskeletal injuries occur each year and 5 million Americans suffer soft tissue injuries annually – a direct result of the nation’s aging population and the broader age span of Americans leading more active lifestyles. The arthroscopy market forecast for 2004 is expected to grow beyond $580 million, according to Millennium Research Group, a Toronto-based healthcare market research and consulting firm, and other research analysts predict the arthroscopy equipment market could hit the $2 billion mark
by 2010.

"Demographics and physicians’ need for revenue streams are big drivers of growth," noted Patrick Driscoll, orthopedic industry consultant and president of MedMarket Diligence, Foothill Ranch, CA. "Innovation in arthroscopy is largely incremental at this point, adding icing to the cake."

MedMarket Diligence specializes in market research of devices, biomaterials, biotech and biopharm used in various clinical areas, including othopedics and musculoskeletal procedures.

From removal to repair

One area of arthroscopy that has vastly improved due to innovations in product and technique is that of meniscal repair.

Today, a growing number of surgeons are attempting to repair torn meniscus whenever possible, rather than just removing it like they had in the past. The meniscal repair segment, which industry experts say has nearly doubled in size, has been propelled by several key technological advancements, most notably those related to bio-resorbable materials that aid healing and are safely absorbed by the body after the tissue has healed.

Bioresorbable materials can be designed for both hard and soft tissues. In contrast to metal implants, certain mechanical properties of bioresorbable materials are closer to those of natural bone, which may reduce weakening of the healing bone. And because these materials do not obscure radiographs or MRI/CT scans, they allow for more accurate evaluation during the healing process.

Further contributing to their value is that bioresorbable materials do not dramatically increase arthroscopic procedure costs – an enormous benefit to cost-conscious hospitals and surgery centers.

"Bioresorbable materials are really changing the face of arthroscopy," noted Konsin. "They are replacing titanium
screws and anchors, and at only a slight cost premium. When you compare the total procedure costs, there is not a huge difference, and that has helped drive the market."

Advanced polymers will likely catapult the use of bioresorbables even further. Vendors agree these materials will become more readily absorbable in the near future and may even promote bone growth to fill the space once occupied by screws and anchors. As surgeons look for ways to further minimize holes in bone and soft tissue, liquid polymers may also make their way into product portfolios.

In recent years, the arthroscopic industry has witnessed a surge in the number of arthroscopic shoulder procedures performed – a trend that sources believe can be attributed to advanced surgeon skill and better cost incentives. Konsin said that in the past, there hadn’t been an economic incentive for surgeons to perform shoulder procedures arthroscopically, even though they had the skills to do so. Today, however, he said "there is a more level playing field in terms of reimbursement," which is prompting growth in the subsector.

Of course, technological advancements are also fueling the growth. In a paper published in the July/August 2003 edition of Arthroscopy: Journal of Arthroscopic and Related Surgery, the author stated that "the Holy Grail of arthroscopic shoulder surgery would be a technique using a device that would allow transport of soft tissues under some tension, and then would produce firm fixation of the tissues to bone without the need to tie knots."

Arthroscopic equipment manufacturers are now introducing products that can make that claim. The AutoCuff System from San Juan Capistrano, CA-based Opus Medical, for example, combines a suturing device and a knotless fixation implant, providing surgeons with a knot-free method of suturing tissue to bone. Linvatec, the Largo, FL-based subsidiary of ConMed Corp., recently introduced its UltraFix Knotless MiniMite, a suture anchor system designed for anterior shoulder instability procedures. Smith & Nephew also introduced a new, single portal tissue repair system for rotator cuff and gleno-humeral instability repair in the shoulder, which incorporates pre-tied, sliding knot technology that eliminates the need for suture management and the tying of complex knots associated with traditional shoulder surgery.

Driscoll predicts the growth of arthroscopic shoulder procedures will continue well into the future. "In terms of overall volume and untapped potential, I believe shoulder procedures are likely to see continued growth as a result of increased surgeon skill, complexity of the joint and the increase in the aging patient population."

According to Steve Jones, director of business development for Arthrex Inc., Naples, FL, approximately 60-70% of surgeons are now performing arthroscopic shoulder surgery – up dramatically from an estimated 5% just five years ago.

Digital development

Arthroscopic equipment that has been in place for decades is also getting a facelift, thanks in great part to the proliferation of digital technology in the operating room. Arthroscopic equipment manufacturers are offering centralized, customizable operation room systems that standardize and integrate different imaging components.

Endoscopes, cameras, fluid management systems and power instruments are all being seamlessly integrated into customizable OR systems, alongside high-definition monitors and wireless camera heads, among other technologies, which promise greater data capturing flexibility and enhanced image viewing. The premise behind these digital ORs is to combine technology and maximize space to reduce procedure and turnover time, and enhance surgeon control. Smith & Nephew, Karl Storz, Linvatec, Stryker Endoscopy and Olympus are just a few manufacturers offering such solutions.

"The goal is to offer customizable solutions that make sense for the long-term," noted Alex Seifert, director of surgery center systems for Arthrex. Arthrex and Olympus have partnered to integrate their platforms and specialties.

As part of its ALPHA O.R. Totally Customized O.R., Olympus offers the VISERA Multi-Specialty Digital Imaging Platform – an integrated system that allows the user to specialize each procedure while maintaining standardization. VISERA enables high-quality still and moving digital images to be recorded, stored and forwarded with minimal degradation and also powers digital rigid, deflectable tip and flexible EndoEYE videoscopes for use in the operating room, ambulatory surgery center or for office-based surgical procedures. EndoEYE’s seamless, one-piece technology includes a color CCD miniaturized camera at the distal end of the scope for enhanced visualization.

Culver City, CA-based Karl Storz’s digital imaging platform includes an all-digital camera system, an image capture device with a 10-inch touch panel interface and a medical grade LCD flat panel display. The platform includes serial digital interface video compatibility, producing high resolution and high fidelity images.

Not surprisingly, wireless Palm technologies are also gaining ground, enabling surgeons to capture data from digital systems and download onto other systems
outside the OR, which further enhances efficiency and patient care.

Innovative camera technology that limits – and even eliminates – distortion is making its way into the marketplace. For example, the distortion-free optics of EndoEYE gives the surgeon a better view and more detailed information, and prevents the illusion of "looking through a

keyhole," explained Michael Malave, arthroscopy product manager, Olympus America Inc., Melville, NY.

Enhanced design

Another technological advancement for the arthroscopy sector is the development of equipment that can withstand steam sterilization. Some manufacturers, including Olympus, Karl Storz and Smith & Nephew, are even offering complex camera systems designed for autoclave sterilization.

"With autoclave technology, we can reduce processing costs, capital investment costs and turnover times, which increases efficiency. Instead of having surgeons wait for equipment to be processed, the equipment is usually waiting for them," said Malave, adding that facilities that handle approximately 1,500 cases a year can save thousands of dollars annually by switching from peracetic acid or plasma gas cycles to autoclave.

Manufacturers’ shift toward limited use products can also help facilities save a bundle. In fact, Seifert said switching from a completely disposable program can save up to several hundred dollars per procedure, depending on the level of implementation of limited use products.

Ergonomics are playing a greater role in arthroscopic equipment design as well. Lighter, more powerful shaver systems that remove tissue more effectively, yet reduce hand fatigue are just one example, according to Konsin.

Of course, with the advent of such innovative, high-tech equipment comes the challenge of maintaining user-friendliness, while at the same time, increasing durability and overall effectiveness. Fortunately, manufacturers appear to be committed to meeting those requirements.

Olympus and Arthrex, for example, have made market-focused product design a core part of their development process. In some cases, that entails eliminating parts that have a tendency to become lost, damaged or broken during processing. "If it’s not staff-friendly, we refine the design until we get it right," said Malave.

Moving forward, Driscoll said that continued enhancements to product design, cost and technique will be paramount to maintaining the arthroscopy sector’s firm hold in the surgical arena.

"The one drawback to its maturity is that it is likely to become the subject of cost reduction unless clinicians and manufacturers are able to add value to the procedure," he noted, adding that this would likely translate into even less trauma and shorter recovery times.

Even so, "arthroscopy is well established, with few technologies likely to displace it in the near future," predicted Driscoll. HPN

New  Technology

Biomet gets clearance for femur device

U.S. regulators approved a device from Biomet, Inc. to help build bone in patients with cancer of the distal femur. The company said it would pursue U.S. Food and Drug Administration clearance to sell the product, called ComPreSs, for patients with implants of the knee, hips, shoulders or elbows. As the first of its kind to be introduced into the orthopedic market, the ComPreSs(R) System has been primarily used in patients with tumors in the distal femur. It has been used in conjunction with a total knee implant and consists of several springs stacked inside a porous-coated metal shell. The porous coating allows bone to grow onto the system, securing the implant in place. Dr. James Johnston, director of musculoskeletal oncology service at Kaiser Permanente Medical Center in South San Francisco and professor emeritus of orthopedic surgery and clinical radiology at the University of California, San Francisco (UCSF), was the first clinician to apply the device in a clinical setting. The system has been studied for more than 10 years. Additional clinical sites utilizing the system include: the University of Florida Department of Orthopaedics and Rehabilitation, Memorial Sloan-Kettering Cancer Center in New York, The University of Texas M.D. Anderson Cancer Center, St. Luke’s Medical Center in Phoenix and Huntsman Cancer Institute at The University of Utah.

The American Medical Association (AMA) has established a new CPT code for the procedure associated with the implantation of the Vasca LifeSite(R) Hemodialysis Access System. This code became effective January 1, 2004. The new code, CPT 36566, is specific to the procedure for implanting the LifeSite System. The availability of a unique CPT code will allow physicians and hospitals to differentiate the procedure for implanting the system from the placement of older technologies like hemodialysis catheters when completing claims forms after providing this service. The AMA has also established additional new CPT codes which describe other typical procedures associated with the subcutaneous hemodialysis access system. Approximately 6,000 patients have utilized the LifeSite System for hemodialysis access in the United States since it received FDA 510(k) Clearance in August 2000.