Physician-Invented Device for the Treatment of Hammertoes Finds Success

At AdvaMed 2012—The Medteh Conference, Yuanli Liu, Ph.D., senior lecturer on international health at Harvard University, pointed out that one way in which the medical device industry differs from pharmaceuticals is that medtech allows a space for a broad spectrum of individuals to innovate and invent. Doctors, too, can be inventors—the realm is not reserved only for engineers. Scott Roman, M.D., a podiatrist-turned-inventor, has helped many patients with proximal interphalangeal joint flexion deformity (more commonly known as hammertoes) with his Arrow-Lok Digital Fusion System, now marketed by Collierville, Tenn.-based Arrowhead Medical Device Technologies LLC.

The traditional surgical approach for correcting hammertoes utilizes a Kirschner wire, or “K-wire,” to hold the bones of the toes in position after surgery so they can fuse into the correct alignment. Since the technique was popularized more than 40 years ago, smooth 1.1 mm or 1.6mm K-wires have become the most common fixation for proximal interphalangeal fusion. The wire usually is left protruding from the toe for four to six weeks after surgery.

“Not surprisingly,” Roman said, “that causes anxiety for many patients, who worry about stubbing the toe with the wire sticking out, or even accidentally pulling it out.”

There are other difficulties related to use of external K-wires. Their protrusion can increase the risk of postoperative infection; the wires have to be removed before the bone has completely healed, which can be an uncomfortable procedure for the patient; and K-wires may simply not be stable enough, leading to internal instability or even failure of the fusion.

“I used to embed a short wire to provide a balance of effectiveness and comfort for my patients but stability was not as solid as I wanted it to be,” said Roman. “The segments of the toes would sometimes distract off the wire or gap at the fusion site . . . we needed to overcome the challenges of the current procedure and create a better approach.”

Roman envisioned an arrow-shaped device that could be used in place of the traditional external wire. The challenges of taking a medical device through the U.S. Food and Drug Administration (FDA) clearance process and creating a national distribution channel, however, presented hurdles that Roman, already involved in a busy medical practice, could not meet on his own.

“I had ideas, I had prototyping,” Roman recalled, “but I didn’t have a team of experienced professionals supporting me.”

At the urging of a professional associate, Roman connected with Patrick Mullaney, whose 20-year career has largely been focused on selling and commercializing medical devices. Recognizing the originality and market potential of Roman’s hammertoe device, Mullaney and Tom Twardzik, a professional associate with 25 years in the industry, co-founded Arrowhead in 2010. The company is focused on introducing new devices to treat musculoskeletal disorders.

Roman’s hammertoe solution became the company’s first product. The initial design received 510(k) FDA clearance in the fall of 2010, which allowed doctors to start using the product in patients. Feedback from surgeons led to the development of a “second generation” implant design that made the product easier to use and able to fit a wider range of patient anatomies. The new Arrow-Lok system was cleared in October 2011.

“Launching a new medical device is a daunting task,” Mullaney said. “You have to finalize the design, implement production, develop a compelling message, and create a distribution network. Your people on the street personally present the product to the surgeons and support its use in the OR [operating room]. Sales representatives are the actual human contact you have with the users, hospitals and surgery centers. We are very selective about who represents Arrow-Lok technology, and work through a network of independent agents in strong markets. That’s allowing us to rapidly gain acceptance of the Arrow-Lok System among leading podiatric and orthopedic surgeons.”

Since the system’s availability in December 2010, Roman has used it on his own patients, “both young and old, with excellent results. The system is designed to maintain stability until the bone is fully healed, to reduce patient anxiety about the removal of external wires and to reduce the possibility of postoperative infections.”

“I’ve had several patients that have been putting off surgery for years because they didn’t want to go through the experience with the external wires, the most common manner of fixation,” Roman continued. “The Arrow-Lok system is a comparatively anxiety-free post-op experience for them. As we bring the device to doctors across the country, the patient population will become more aware of the product, and discover that they can have hammertoe surgery without wires protruding from the ends of their toes. That’s when they will begin requesting to be treated with a product like the Arrow-Lok device.”

In determining whether surgery is appropriate for a given patient, Roman always starts with the most basic, and important, consideration: “The first question I ask patients is if they are experiencing pain that alters their activities of daily living. When the benefits outweigh the risks of surgery, that’s the time to have the procedure to get the toes corrected.”

Roman’s own mother had experienced pain and physical difficulties after two surgeries using K-wires had failed. “One was an internal wire and one was external, but they both failed,” Roman said. “The Arrow-Lok device worked well on my mom, and now she’s fine. It’s gratifying to watch her keep up with my kids without the discomfort that caused her to limp.”

“That’s really the point of creating this new system,” Roman continued. “I want to help my patients regain what they’ve lost. If you can wear shoes comfortably and do the things you want to do, it’s a great improvement in the quality of life.”

Arrowhead Medical Device Technologies LLC develops, manufactures and distributes medical devices that treat musculoskeletal conditions. The company plans to expand the Arrow-Lok technology to a full line of various sizes and applications.

Image of Arrow-Lok Digital Fusion System courtesy of Arrowhead Medical Device Technologies LLC.