Arthrex C3 Program

If we could peer into the portals of the arthroscopic market, we would see an area ripe for growth, driven by customer demand, new technologies and increased surgeon interest. A market that has been gaining momentum over the last few years is well-positioned for additional growth in 2005.

As baby boomers continue to remain active in sports and other activities and have an increasing need to have articulating joints repaired, and with the availability of more convenient places where arthroscopic surgery is performed, the trend will only continue, said John Konsin, vice president of marketing, Smith & Nephew Endoscopy (Andover, MA). "Surgeons have been very aggressive in setting up their own ambulatory surgical centers (ASCs), and hospitals have invested in ASCs. It’s increased the availability of where a patient can have arthroscopic surgery done, and have it done pretty easily," said Konsin.

Another driver for the arthroscopy market is that the patients themselves are becoming more aware of their options involving arthroscopic surgery and feel more comfortable pursuing it as treatment, noted Joe Metzger, director of corporate communications for Smith & Nephew.

In addition, there is a continuing focus on the part of surgeons that is driving the arthroscopy market, fueled by an influx of new products by manufacturers.

Opus AutoCuff System

"Whenever new products come out – new approaches, new techniques, new instruments – surgeons get involved, get interested and they evaluate. And that overall helps the market itself," said Konsin.

"There is a definite trend towards increased use of minimally invasive methods," added Matt Fahy, director of marketing for surgical products, Olympus America (Melville, NY). "Traditional arthroscopic procedures are performed by more and more orthopedists and new approaches are being developed, such as minimally invasive hip replacement."

Yet another factor that could contribute to growth in arthroscopic procedures involves the controversy surrounding the use of anti-inflammatory drugs as a remedy for chronic arthritis pain. In his new Medical Blog, www.kneehippain.com, Dr. Ronald P. Grelsamer, stated, "Some people believe that non-operative options are safe and that surgery is the ‘aggressive,’ riskier option. In the hands of a prudent surgeon, however, surgery is always the conservative choice – and the current anti-inflammatory (NSAID) controversy brings the issue to the fore. By taking anti-inflammatory medication such as Celebrex, Naproxen, Ibuprofen, or Diclofenac for knee arthritis, a patient manages to live with the pain. Without the NSAID, however, he or she might experience extreme discomfort. With a knee replacement, the arthritis is gone forever and so is the need for chronic reliance on an NSAID. In many cases, the ‘conservative’ choice is surgery."

In particular, this year should prove to be a big one for arthroscopic shoulder surgeries, a trend that began several years ago. "Without a doubt, we’re going to continue to see the growth we saw in 2004 for shoulder arthroscopy, which was in the mid-teens," said Konsin.

Hip arthroscopy, seen as an even more challenging surgery to perform than shoulder arthroscopy, is shaping up to be the final frontier among the highly segmented, highly specialized arthroscopy market. "Hip arthroscopy is nascent, or just emerging," said Konsin. "It’s almost premature to talk about significant growth in hip arthroscopy because it’s such a small base right now. I’d say 2005 will be the year of interest and intrigue if you will."

He notes that hip arthroscopy surgeon training courses were regularly being booked to their full capacity at the tail end of 2004. Why? "Because doctors and surgeons are interested and intrigued. They are asking, ‘Can I do this? What’s the benefit for me and my practice? What’s the benefit for the patient?’" he said.

Olympus TrueView II

Konsin predicts that the trend towards segmentation in the arthroscopy market will also continue in 2005, both in where arthroscopy procedures are performed and in procedure specialization within practices. "Surgeon-owned ASCs; hospital-owned and operated ASCs; and hospital outpatient departments are all run a little different and they’re all growing in importance. They all have something a little bit different to offer." In addition, he adds, whereas practices historically had no more than a knee arthroscopist on staff, "now we’re seeing multi-physician orthopedic practices branch out into having also a dedicated shoulder surgeon, a dedicated small joint surgeon and maybe even a dedicated hip arthroscopist."

Lowering the learning curve
Just as surgeons are considering adding new surgeries to their repertoire, device manufacturers are coming up with new products to help them more easily reach their goals.

One product that’s on the market to help lessen the learning curve for arthroscopic surgeons attempting hip surgeries is Smith & Nephew’s Hip Access System which helps provide safe placement of working channels. Konsin remarks that finding proper channel placement is often a considerable barrier to hip arthroscopy.

"It assures doctors who are thinking about hip arthroscopy by taking the fear factor out of where to put portals," said Konsin. "We believe that by introducing the system, you’re going to get more doctors interested in hip arthroscopy."

That’s a boon for patients as well, notes Konsin. "Many surgeons believe that by removing foreign and loose bodies in the hip joints, you can dramatically benefit patients that have hip pain.

"Everybody wins. The doctor feels more comfortable doing hip arthroscopy, facilities win because they’re doing hip arthroscopy procedures that they didn’t offer before – they have more solutions for patients. And the payors win because they have a satisfied client base that has less hip pain," he added.

Smith & Nephew Hip Access System

Shoulder arthroscopy products introduced by Smith & Nephew in 2004 include the BioRaptor 2.9 Suture Anchor and the Ultrabraid Polyethylene Suture. The stronger suture material of the Ultrabraid is designed to provide secure knot tying for arthroscopic shoulder procedures, in particular for surgeons who tie rather tight knots that might previously break under the stress. The BioRaptor 2.9 Suture Anchor is designed for an area of arthroscopic shoulder repair called instability repair, a previously unmet need for Smith & Nephew. "We now meet the needs across a full product line for most shoulder arthroscopists," said Konsin.

Suture control is yet another daunting task that can deter surgeons from learning arthroscopic procedures. The Elite Pass Premium Arthrsocopic Suture Shuttle by Smith & Nephew was designed to help overcome the obstacle of trying to maneuver as many as six strands of suture through soft tissue with traditional "knitting needle-type" suture control instruments. The shuttle, which has the needle and thread in the unit itself, allows the surgeon to grab the sutures, easily move them around and eventually get a very nice secure knot. "It’s made it easier for the surgeon that is just beginning to do more arthroscopic cases," said Konsin.

Smith & Nephew also offers education opportunities for surgeons and their staff who are interested in new products and techniques.

Through its 2004 purchase of Opus Medical, ArthroCare Corporation (Sunnyvale, CA), now provides a solution that helps surgeons overcome difficulties with knot-tying in rotator cuff repair surgeries through the Opus AutoCuff System. "Orthopedic surgeons benefit from the AutoCuff System because it has a relatively short learning curve, reduces surgical trauma, and makes total arthroscopic rotator cuff repairs faster and easier," said Vivek Sama, M.D., associate director, Opus products and business development, ArthroCare Sports Medicine.

The Opus system actually eliminates knot-tying all together through the use of a patented mattress stitch. The AutoCuff’s SmartStitch Suturing Device places an Incline Mattress stitch directly into the rotator cuff tissue in less than five seconds. Then the system’s Magnum Implant, with sutures loaded, is inserted into a pre-drilled hole in the bone. The Implant has built-in cinching and suture fixation mechanisms.

The AutoCuff system promises to cut operating time by as much as 50%, as well as eliminate the stress risers that can result around a traditional knot in shoulder arthroscopy. According to Dr. Sama, surgeons transitioning from open to arthroscopic rotator cuff repair may benefit from using the system first in a mini-open procedure before attempting a fully arthroscopic rotator cuff repair.

At the heart of arthroscopic procedures, of course are the optical imaging capabilities available through arthroscopes and other imaging components. According to Fahy, the outstanding image quality, ergonomic handling and ease-of-use of the Olympus TrueView II Arthroscope make it a natural fit for surgeons learning arthroscopic procedures. "For arthroscopy in particular, the proper equipment makes a clear difference and reduces the learning curve."

Smith & Nephew Ultrabraid Suture

The company’s TrueView II Arthroscope incorporates a wide screen, 115-degree field-of-view that facilitates navigation in the joint with fewer scope rotations, increases the amount of image information and allows for earlier detection of shavers and radio frequency probes. The TrueView II also gives the added advantage of being ergonomically easier on the surgeon, helping to reduce fatigue and thus making the surgery easier to perform. Features such as its quick-lock camera connector help make scope exchange seamless.

Karl Storz Sports Medicine (Culver City, CA) has also made a commitment to offering superior visualization products. "Superior optics offers a superior arthroscopic image, leading to improved surgical outcomes," said Winifred Shannon, product marketing manager, Karl Storz.

Cost-saving opportunities
One company that is taking a different approach to cost containment in arthroscopic procedures is Arthrex Inc. (Naples, FL). With its C3 (Comprehensive Cost Containment) program, Arthrex offers a new capital equipment program for arthroscopic outpatient facilities. Alex Seifert, director surgery center systems, Arthrex, notes that the two main objectives of the C3 Program are to reduce costs associated with capital equipment and to reduce per procedure costs associated with using disposable and consumable items.

"What we learned in 2004 is that people are really looking at cost containment programs as a means of reaching their own financial objectives especially new construction facilities that don’t have a lot of surgeries or existing facilities who may not be as profitable as they need to be or want to be," said Seifert.

Through the C3 program, Arthrex and its distributors will invest some, or the majority, of the costs of capital equipment while the customer signs an agreement for the use of consumables over a period of time. These consumables are designed to save the facility money as well.

"We offer consumable products that have been engineered and designed to reduce per procedure costs," he said.

Included in the C3 program are four components, the first of which is a fully autoclavable video optical chain supplied by Olympus through an exclusive distribution contract with Arthrex. Also included are three products manufactured by Arthrex, including the APS II (Adapteur Power System) shaver for tissue resection, the OPES electrosurgical units (Orthopedic Procedure Electrosurgical System), and the Continuous Wave Pump.

Seifert notes that the Olympus arthroscopes, camera heads and light cords are fully autoclavable which is an excellent cost-saving measure. "Autoclaving is pennies on the dollar compared to about $15 for soaking methods," he added.

Autoclaving is endorsed as the preferred sterilization method by the AORN (Association of PeriOperative Nurses), according to Fahy, "It significantly reduces sterilization costs, is environmentally friendly and creates no exposure to toxic chemicals, fumes or gases, such as with ETO," he said. "In addition, autoclavable arthroscopes can be turned around faster," an equally important cost-saving benefit.

Olympus backs its autoclave claims with a 5-year warranty on all its Goldtip telescopes and the TrueView II arthroscopes, guaranteeing their ability to withstand repeated autoclave cycles. All components – including the telescope, trocars, light guide cables and camera head – are steam autoclavable, he said.

Karl Storz Powershaver SL

Arhtrex’s OPES is a three-in-one function electrosurgical unit that allows for ablation, arthroscopic electrodes and bipolar forceps in one all-inclusive cost-saving unit. The Continuous Wave Pump provides cost savings through its 2-piece tubing system that couples a main pump tubing set with an inexpensive disposable patient tube set. Only the disposable patient tube gets thrown away after each case, which Seifert notes not only saves money, but also saves the exchange time for turning over the pump tubing between cases. The system also saves the expense of discarding fluid after each case. Arthrex offers both limited reusable shaver blades and disposable shaver blades for its APS II shaver.

Arthrex qualifies a facility for the C3 Program through an assessment of the facility’s annual arthroscopic volume, types of cases, facility size, amount of equipment needed, among other factors, he said. "We customize each C3 program according to the specific needs of our customers," he added. (Visit arthrex.com for more information.)

Boston Outpatient Surgical Suites (BOSS), located in the Health Point pavilion (the training facility of the NBA’s Boston Celtics), offers the latest advances in the treatment of sports related injuries with a procedure volume of 2,200 arthroscopies per year. While analyzing the capital equipment programs of various companies, the physicians and administration of BOSS visited Arthrex headquarters to review the C3 program and products.

Having already adopted a fiscally responsible cost containment philosophy, the BOSS team determined the C3 Program would deliver product performance and efficiency in the OR and improve procedure cost management. After considering fee-per-use leases, financing of capital equipment, and cash purchases, the facility opted for three complete C3 Systems from Arthrex. The end result has been considerable consumables savings (operating costs) over competitive fee-per-use programs of $7,647 for one month, $91,770 for one year and $275,310 anticipated savings over three years. Also, BOSS experienced an immediate capital equipment savings compared to fee-per-use and other lease programs.

In addition to these savings, the facility enjoyed no start-up costs for capital equipment, plus no commitments to monthly minimum purchases, allowing for ramp up of cases without the financial burden of monthly lease payments. Arthrex was able to install and in-service the C3 Systems before Medicare and managed care contracts were finalized.

Yet another cost-savings opportunity presented by Arthrex is its full service contracts available through Olympus that cover arthroscope and camera-head repairs. Seifert explains that instead of charging on a per-case basis, the Olympus contracts work more like an insurance policy, in which the facility is charged a one-time flat fee per scope and camera head that covers the item for the entire year. Seifert estimates that the program can provide a reduced price of as little as 1/20th the cost of standard service contracts. "If the product breaks, it’s already paid for, and a replacement product is sent within 24-48 hours," he said.

Karl Storz offers a field-based service program in which Karl Storz-trained technicians call directly on hospitals and surgicenters, meaning products can be serviced in-house without having to be sent back to the manufacturer, minimizing surgery down time. "When a product goes down, having the comfort of rapid turnaround through hospital-based or overnight repairs reduces the risk of cancellations and delays in surgery," said Shannon.

Karl Storz is offering both disposable and limited reusable blades for its high-speed, high-torque Powershaver SL, allowing customers to make the best economic decision for their budget, said Shannon. Introduced in 2004, the Powershaver SL completes the company’s arthroscopic video tower offering. According to Shannon, the Karl Storz shaver features the highest speed and torque currently available, for a more efficient procedure. "This product has the speed and torque required for even the most challenging surgical procedures, but also offers the flexibility to control speed and operating mode from the handpiece, footswitch or console touchscreen," she adds.

In surgery, time savings almost always equals cost savings, and several manufacturers have developed tools to help cut the amount of time patients spend in the operating room.

Smith & Nephew BioRaptor 2.9  Suture Anchor

In addition to the time-savings that can be achieved through its AutoCuff system, ArthroCare offers several other products designed to shave minutes from arthroscopic procedures. "OR time savings, as well as cutting back on patient recovery times, are key factor in improving the profitability of arthroscopic procedures," said Andre Bessette, director of marketing, ablation products, ArthroCare Sports Medicine. "Much of our technology provides access to these factors, and we regularly see the clinicians with whom we work enjoy the bottom line benefits."

ArthroCare’s ArthroWands use an advanced form of RF technology, called coblation, to remove tissue and provide coagulation in one tool. The benefits are not only time savings in the OR, but also faster patient recovery as well, notes Bessette. Coblation dissolves tissue at relatively low temperatures (typically 40°C to 70°C). The result is volumetric removal of target tissue with minimal damage to surrounding tissue.

Another ArthroCare Product, the TOPAZ MicroDebrider is specially designed for treating tendons in the shoulder, knee, ankle, foot and elbow. Its slim-line design offers easier access to target tissue and its narrow shaft diameter enables physicians to create small shallow impressions. This 20-minute outpatient procedure promises rapid recovery for patients.

New products on the horizon
Without a doubt, new arthroscopy products will emerge throughout 2005 that will continue to advance surgical techniques and outcomes.

"In 2005, you’re going to continue to see in this industry, more emphasis on products that will help improve outcomes and reduce time in surgery. Because ultimately that’s a win-win for everyone involved," said Konsin.

Smith & Nephew recently introduced its GTS System for use in arthroscopic ACL reconstruction. The system is used to secure the tibial end of a soft tissue ACL graft using a fixation screw made of bioresorable PLLA (poly-l-lactic acid) that is naturally dispersed from the body over several years. The company has plans to continue its focus on arthroscopy with additional new products in 2005.

Smith & Nephew Elite Pass Suture Shuttle

Karl Storz has also made a corporate decision to focus on the arthroscopic market for the year ahead, said Shannon. The company’s product focus for 2005 will be its arthroscopic video tower, which includes the Powershaver SL, optics and hand instruments.

According to Bessette, ArthroCare Sports Medicine will place a heightened emphasis on its shoulder arthroscopy products for 2005. The company’s Opus division is introducing its LabraFix System for repair of Bankart lesions in the shoulder in March of this year.