Spine surgery has become increasingly less invasive over the past decade. Even the more complex deformity and tumor cases now have technology allowing surgeons to perform less disruptive procedures, and despite a challenging regulatory environment there is still huge opportunity for growth and innovation in the spine arena.
"Much of the innovation in spinal deformity today is geared towards the pediatric population and how to treat patients at a younger age and to improve the success rate in treating spinal deformities," says Krishn Sharma, M.D., a spine surgeon with Scoliosis & Spinal Surgery in White Plains, New York, and a member of the design team for Precision Spine's Reform® System. "I think one of the biggest opportunities lies with the aging population. Older patients are healthier and living longer and there will be more patients being treated for spinal deformities over the age of 65. That means more patients with osteopenia/osteoporosis being treated surgically."
Precision Spine is one of the companies today making an impact on the spine field by creating products that feature technology and techniques that are designed to be less invasive. The company began its current efforts in the orthopedics and spine market four years ago as a small company designing products to differentiate their offering. They moved forward with a design for their triple-lead pedicle screw system with a goal to decrease physician fatigue during long scoliosis and adult deformity procedures.
"The triple-lead screw is difficult to manufacture, but is designed to provide an advantage for surgeons because every one complete turn with the system equals three turns with the normal pedicle screw system," says James Pastena, Chairman and CEO of Precision Spine. "When you're placing 20 to 30 screws, that can have a huge impact on surgeon fatigue, OR time and blood loss."
Designing the system
The system was designed by a team of experts and experienced surgeons ranging from six to forty years of experience with spinal instrumentation. The surgeons had used several systems on the market and brought their positive and negative experiences into the development process.
"The multiple surgeon input into the screw design and implantation is anticipated to make the system more user-friendly and provide universal application for both simple and complex deformities and degenerative disease," says Rudolph F. Taddonio, M.D., a spine surgeon with Scoliosis & Spinal Surgery and a member of the design team for the Reform® System. "The development process went through various iterations as we looked into different design parameters and applied our models to cadaveric specimens to test ease of use."
The developers spent hours in the lab and informal settings, shared telephone discussions and reviewed designs and drawings for specifications while developing the system. There were some surprises; some ideas that the team thought would work well on paper didn't when taken to prototype. However, the team went back to the drawing board and was able to address the issues.
"Reform® was designed with both the surgeon and the patient in mind," says Dr. Sharma. "From the surgeon's perspective, it was designed to have high pull-out strength and a low-profile cobalt-chrome tulip head. It's a pedicle screw system that we anticipated can be used in both adolescent and adult situations. It has a triple-lead thread design which is designed to make implanting multiple screws quicker and less tiresome for the surgeon. The lower-profile design is expected to make irritation from the hardware less likely in thinner or smaller patients."
The Reform® System received FDA 510(k) clearance in August 2012 for use in patients with severe spinal conditions. Because manufacturing the system is so complex, Precision Spine decided to keep operations in the United States to carefully monitor how products were manufactured at a time when many companies were taking manufacturing oversees. "We expanded our plant in Jackson, Mississippi so we could control quality from the inside," says Mr. Pastena. "We manufacture about 70 percent of the company's products at that facility."
Regulatory burden
Healthcare reform has brought several challenges to the medical device industry, including the medical device excise tax and tougher regulatory requirements, but products with a clear advantage for the field will continue to succeed.
"It's a challenging and changing market, but we believe that innovation is still going to be at the core of the reason why companies are doing well," says Mr. Pastena. "We want to be at the forefront of that."
The shorter surgical times that are anticipated due to the Reform® System's unique design could afford several advantages, including:
• Shorter OR times
• Less blood loss
• Lower cost
"We are seeing a large number of surgeons adopt this product right now, and we're just scratching the surface," says Mr. Pastena. For surgeons considering using the system, it could be beneficial to perform less complex cases at first.
"Surgeons may want to consider first using the system in lumbar degenerative surgery in one, two or three level fusions so they can learn the instrumentation and become facile with it," says Dr. Taddonio. "Every surgeon has preferences and knows how instruments feel in their own hands. There are also opportunities for custom instruments to fit the surgeon's preference."
Future innovation
Innovation in the spine field can seem incredibly slow, especially for developers working day-in and day-out. There has been some innovation in metallurgy using smaller alloys and lower profile implants — some are still in the testing phase and others have fallen by the wayside because clinical results didn't hold up.
"The minimally invasive systems are supposed to make the patient experience better, but if the fusion rate isn't acceptable, those methods will likely need further development and testing before they reach the gold standard," says Dr. Taddonio. "We are currently engaging in a time study to better determine the time it takes to insert various diameter pedicle screws into one- and two-thread design systems with the Reform® System."
Future development in pedicle screw insertion also lies in image guidance for precision and safety. The financial feasibility of adopting new technology will also play a part in future development.
Precision Spine also has a worldwide exclusive license to bring in a new way to perform spine procedures using rare earth magnet technology to address different spinal pathologies. There is work being done on it aggressively, but will take time with today's regulatory environment to bring it to the marketplace.
"Emerging systems, like Reform®, are designed to allow the highest level of care to be achieved across the age spectrum from young to old, in a cost-competitive and time-saving manner," says Dr. Sharma. "As healthcare costs are further scrutinized, surgeons and hospitals will likely choose implants that are more cost-effective than those of their competitors."
This article is sponsored by Precision Spine.
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