With surgeries, one of the keys to success is precision.
But when it comes to working on a child’s fractured elbow, also known as a "distal humerus fracture," surgeons trying to insert pins to heal the bone have had to pull and twist the arm into place before drilling in the pins. Not the most exacting procedure.
A new Utah company has developed a system that includes a fixture and brace that takes some of the guesswork out of resetting such a fracture.
Fixes 4 Kids Inc., has created the E-Fix Supracondylar Humerus Fracture Reduction and Pinning System — E-Fix for short — and the E-Thotic perioperative orthosis, or E-Thotic, to make the procedure more exacting and easier to do.
"If not put back together [correctly], it could have devastating consequences," said company founder and CEO Kurt Vedder. "We’ve built technology that we believe will take the treatment of children into a new stage of medical care. We believe the technology will provide the physician with benefits and advantages, as well as the patient."
The E-Fix and E-Thotic made their debut in March at the American Academy of Orthopedic Surgeons Annual Meeting in Chicago and are being introduced to the market now. Both have been approved by the Federal Drug Administration.
The E-Fix device is a metal and plastic contraption with knobs and handles that looks like it belongs in a metal shop, but it took years of engineering development and more than 20 prototypes to reach this point, Vedder said.
It is connected to a table where the arm of the child with the broken elbow is inserted into the E-Fix while the patient is under anesthesia.
The doctor can then move the E-Fix up to six degrees and on three planes to adjust the arm. The pins are then inserted using the E-Fix guidance system. During the procedure, the child is also wearing the E-Thotic, a specially-designed arm brace that supports the upper and lower arm, and that also is worn after the surgery instead of a cast.
Before the E-Fix, two people usually were required to insert the pins, which meant one had to hold the arm as steady as possible. With the E-Fix, it’s a one-person procedure, and because the E-Fix is holding the arm when an X-ray machine is used, the physician no longer is exposed to the harmful rays.
"Before, they had to hold the patient’s arm down, and someone either had to hold the arm down or drill the pins in," said Fixes 4 Kids marketing director Joel Melton. "Now, they can do it hands free, and there is more accuracy."
Mizuho OSI in Union City, Calif., an orthopedic surgical device manufacturer and distributor, will distribute the E-Fix and E-Thotic worldwide. Mizuho also is an investor in Fixes 4 Kids.
Dr. Peter Stevens, professor of orthopedic surgery at the University of Utah, has used the system on cadavers and will recommend it to other doctors.
"When you have it [the arm] attached to the frame, you have a steady control," he said. "And it’s infinitely patient, and it never gets tired or moves, unlike a person who has to hold it all the time."
Vedder, a former University of Utah football player, started Fixes 4 Kids in the Silicon Valley in 2009 to develop products for the pediatric orthopedic industry. It started with $4 million from angel and private investors, and now is beginning a second round of investing, Vedder said.
"I have been in medical devices for 20-plus years, and there’s not a lot of companies dedicated to developing and designing and manufacturing orthopedic products for the pediatric space," he said. "That was the goal."
Last summer, Vedder moved his company to Salt Lake City to a building next to the Rio Grande Depot, where there are eight employees. The device is manufactured in North Dakota.
"We’re excited to be back in Salt Lake, and it’s an exciting place to be operating the company," Vedder said. "It makes all the sense in the world for a small company to be working in an environment in Salt Lake with low taxes and more acceptable regulation. It’s hard to run a business in California."
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