As technology continues to advance, so does the ability of manufacturers in a variety of industries to offer customized consumer products. Golfers, for example, can buy customized clubs based on their height, arm extension and game history, instead of buying off the shelf.

Now, consumer demand for customization is finding its way into the medical device industry, and in particular, the orthopedics sector. Thus, ConforMIS (Burlington, Massachusetts) is hoping its new unicompartmental knee resurfacing implant will offer osteoarthritis patients a more customized fit based on measurements obtained from a CT scan. In turn, the company hopes the product will help surgeons feel more comfortable offering the knee resurfacing procedure to their patients.

Currently, there are a lot of unicompartmental knee replacements on the market, Jong Lee, senior VP of marketing for ConforMIS, told Medical Device Daily. But none of these other products are patient-specific, he added. Manufacturers make the implants in about eight different sizes, so when it comes time to put a unicompartmental implant into a patient the surgeon has to do a lot of manipulation of the bones, Lee said. He compared it to putting on a shoe that doesn’t quite fit.

Instead of cutting the patient’s bones to fit the implant, ConforMIS’ iUni is designed to fit the patient by taking imaging data from a CT scan and using the company’s iFit technology.

“We know the size, we know the shape,” Lee said, comparing the process to using a Google map. “We have a roadmap of your knee to make the implant.”

ConforMIS reported launching the iUni unicompartmental knee resurfacing implant and its accompanying iJig disposable instrumentation this week. The device is one of four patient-specific implants it has developed for the treatment of osteoarthritis of the knee, the most common reason for knee replacement surgery, according to the company.

The iUni is a unicompartmental resurfacing implant – often referred to as a partial knee replacement – designed for patients whose arthritic damage is isolated to either the medial or lateral compartments of the knee, with little to no damage present in the other compartments. The device is available for either the medial or lateral compartments and is cleared for marketing by FDA and CE-marked for sale in Europe.

The iUni comes packaged together with patient-specific instrumentation called iJigs, which are designed from the same scans as the implant, including data on the patient’s biomechanical axis. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the instruments, simplifying the surgical technique. The disposable iJigs replace multiple trays of traditional instrumentation and save the hospital hundreds of dollars in instrument handling, storage, and sterilization costs.

ConforMIS develops devices for the treatment of osteoarthritis and joint damages. The Company’s “image-to-implant” process is comprised of two related technology platforms. iFit enables the creation of conforming, patient-specific implants that are precisely sized and shaped to match the 3-D topography of the patient’s anatomy, ConfroMIS said. iJig is designed to enable the creation of disposable, easy-to-use instrumentation that simplifies the surgical process and improves reproducibility.

Because the company is in the early phases with the device, Lee said it is taking about six weeks from the time ConforMIS gets a patient’s scan to the day the company can actually deliver the implant. Over time, he said, the company hopes to get the turnaround time down to about three to four weeks.

“I certainly feel like we’re going to generate a lot of attention, a lot of companies and surgeons taking a look at what we’re doing ... customization is really where a lot of the difference is made from a patient experience standpoint,” Lee said.

Early intervention patients, particularly younger patients – those between the ages of 45 and 60 – are the best candidates to receive the implant, Lee said.

“A good orthopedic surgeon is going to be real reluctant to do a total knee replacement on someone who is 45 because the lifespan of a total knee replacement is about 15 years,” Lee said. “They’ll eventually have to have a revision surgery, which is more invasive and generally considered to be never as good as a primary total knee replacement.”

But with the iUni, patients can get a knee resurfacing implant now and still be a good candidate for a total knee replacement later on, if necessary.

“The launch of the iUni represents an important milestone in ConforMIS’ commitment to advancing the state-of-the-art in orthopedics with our patient-specific, minimally traumatic knee implants,” said Philipp Lang, MD, CEO and chairman of ConforMIS. “Our image-to-implant technology offers physicians a unique, bone preserving option for early intervention combined with a simplified and reproducible surgical technique. We believe the advantages of our patient-specific approach will continue to increase adoption of ConforMIS implants within the orthopedics community.”

Because it is patient-specific, the iUni allows for true resurfacing of the femur and complete coverage of the weight bearing surfaces for each patient, a result not previously achievable with off-the-shelf implants. Complete cortical rim coverage on the tibia, for example, is expected to reduce the risk of implant subsidence and loosening, key failure mechanisms for standard unicompartmental replacements.

“Being able to utilize imaging data to develop patient-specific knee implants provides a significant advantage over existing traditional knee replacement techniques,” said Wolfgang Fitz, MD, of Brigham and Women’s Hospital, a member of the faculty at Harvard Medical School (both Boston), and part of the surgeon design team for the iUni. “The ability to take advantage of this technology for new and unique implant designs and improved surgical techniques should expand both the patients and surgeons who can successfully utilize a partial knee resurfacing product.”