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Interview with Robert Martin, Ascension’s Vice President of International Sales and Marketing 
Ascension Orthopedics Inc. is based in Austin, Texas. Dr. Jerome Klawitter and Dr. Steve Cook founded the company in 1992. The focus of the company is small joint arthroplasty built on a new material platform, pyrolytic carbon.Rob Martin joined Ascension Orthopedics Inc. in May 2000. His mandate is to build the international business. Since joining the company he has increased the number of distributors in Europe to 10 and is expanding into Australia, Asia and the America’s. OPN: I have recently heard about your company from your Great Britain distributor, Osteotech. Can you tell me a little more about it? Martin: Ascension Orthopedics is actually a young company with a long history. The idea for the product was first hatched out in 1976. Dr. Bob Beckenbaugh, of the Mayo Clinic had an idea for a MCP joint made out of PyroCarbon and he approached Jerry Klawitter and Steve Cook. Dr. Klawitter was the Director of Orthopedic Research at Tulane and was intrigued by the idea. They decided to do some animal research to look at the possibilities. The results were excellent. This resulted in Dr. Beckenbaugh implanting the joints in patients from 1979 to 1986. The project was revitalised in 1992 when Dr. Klawitter and Dr. Cook decided to form Ascension Orthopedics. The results of the initial implants were published in the JBJS in 1998 and we received CE mark approval for sale in Europe in late 1999. We now have 19 employees and are actively marketing the product throughout the world. Jerry has put together a very strong and dynamic team of people. We listen to the marketplace and respond quickly. OPN: You talk about Pyrocarbon, this seems to be a new material. Can you tell us more about it? Martin: The material is new for orthopedics but has a long history in medical devices. It was first developed in the 1960’s at the Los Almos labs in New Mexico to be used as an insulator in nuclear reactors. The material was discovered for the use in heart valves in the late 1960’s and has now been used in over 3 million heart valve procedures. What makes it special is it’s material properties. It is extremely strong, wear resistant and fatigue resistant. The elastic modulus of Pyrocarbon is also similar to cortical bone, so you reduce the chances of stress shielding. During the animal testing we also found out that it was extremely bone friendly which allows us to get good implant stability without the use of cement. OPN: Why is it called Pyrolytic Carbon? Martin: The name comes from how it is manufactured. “Pyro” for heat; and “lysis or lytic” for break or cut. OPN: How is the material manufactured? Martin: The material is manufactured by a process called chemical vapour deposition. What this means is that a graphite substrate is introduced into a tank that is heated to 1300 degrees Celsius. A hydrocarbon gas like propane is introduced into the tank and the heat breaks the hydrogen bonds and releases a carbon atom. This carbon atom deposits itself onto the graphite substrate. Over a period of time the surface gets completely coated in pyrolytic carbon. OPN: How thick is the layer of PyroCarbon? Martin: We use a patented process to ensure that our coating process is very reproducible. The thickness is .5mm. OPN: How does this material stand up with regard to strength, fatigue, and wear properties? Martin: As I mentioned before the material has a similar elastic modulus as cortical bone, so this is a positive feature. The strength, fatigue and wear properties were measured against values that we obtained from normal joints. We used these values as our baseline and subjected our joints to even more strenuous tests. All the joints were tested one-third unsupported. Our fatigue and wear tests were for a period of 10 million cycles under a forty-kilogram load and seven kilogram load respectively. We had no failures in the fatigue test. The wear test showed no measurable wear up to 2 microns. There is no other material like it being used today. OPN: If the material is so good, why has it not been used before in Orthopedics? Martin: One of the challenges of manufacturing Pyrocarbon is the coating process. The current technology available today limits the size of the implant that can be coated. It is perfect for small joints but a challenge for larger joints like hips and knees. OPN: Your company is just focused on small joints, what products do you currently offer? Martin: We see the small joint market as being under serviced. The sub-speciality of hand surgery is developing worldwide and it is becoming more advanced and demanding. We are trying to bring some of the technology of the large joint market to the small joint market. The doctors are looking for something that will meet their patients’ needs. Our current product is a MCP joint, developed by Dr. Beckenbaugh. It is an anatomical ball and socket design to mirror a patient’s normal joint kinematics and anatomy. OPN: How has the reception of Ascension been taken in the marketplace? Martin: We are very pleased with the results. As I mentioned earlier surgeons have been looking for an alternative for what they are presently using. We are implanting in almost every country in Europe and our user base is growing. As a company we are very interested in patient results and we want to ensure that we continue to provide strong training and follow-up for our surgeons. We provide follow up forms for any surgeon who wishes to maintain a record of an implant and we will add the information to our database to build useful information for our users and ourselves. OPN: The unconstrained design of the joint is new, can you tell us about it? Martin: The design is certainly new. The history of finger joints has shown that a constrained or hinged device will result in one of three things happening. Either the implant will loosen, the hinge will break or the bone will break. This is well documented in the literature and is due to many factors. The design of the Ascension MCP joint is semi-constrained. It is a ball and socket design with a dorsal prominence, which helps to prevent subluxation of the joint. This allows for more anatomic joint and allows proper movement and prevents the problems associated with constrained devices. Having a semi-constrained device also means that you have to have good soft tissue. This is primarily a soft tissue procedure. We do not recommend this device for use in late stage rheumatoid disease. OPN: With that said, what kind of patient do you recommend this device for? Martin: The indications for use are with osteo-arthritic, post traumatic, and early to mid stage rheumatoid disease. Essentially the surgeon has to be comfortable that they can reconstruct the soft tissue. OPN: How are you currently marketing the products? Martin: I have developed a very good group of distributors in Europe, we now have 10 in the family. Osteotech in England is a prime example. The companies that we use are focused on hand surgery and we provide an extensive training program for each of the sales representatives. I am looking for a company that has a long term commitment to the product line. It takes a lot of investment to help develop this market and we need partners who will work with us. OPN: What is in store for the future? Martin: We are currently working on a variety of new products. The first you will see in early 2001 is a PIP joint developed in conjunction with Dr. Beckenbaugh at the Mayo Clinic and Professor J. Stanley at The Wrightington Institute. We are very excited about this product. Hand surgeons have been telling us that this is one of the biggest indications in their practices. After the PIP, we will continue to develop along the route of small joints with a new product introduced every 6 to 9 months. As for our marketing efforts we are now branching out to Canada, South America and Australia and Asia. It is an exciting time for us. OPN: Rob, thank you for taking the time to tell us about Ascension Orthopedics. Further information about Ascension can be obtained by visiting www.ascensionortho.com |
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