Becker's Spine Review

23 Executive Brief: Precision Spine, Reform, Slimplicity, SureFit, SureLok PC, VAULT, and VAULT-C are trademarks of Precision Spine, Inc. 4040 Copyright ©2014 Precision Spine, Inc. All rights reserved. Precision Spine, Inc. • 5 Sylvan Way, Suite 220, Parsippany, NJ 07054 www.precisionspineinc.com Comprehensive Spinal Solutions Slimplicity ® ShurFit ™ Interbody Cages VAULT ™ Reform ™ SureLOK ™ PC VAULT - C ™ Precision Spine is a spinal device company offering spinal pathology solutions to meet the needs of patients, surgeons and healthcare providers. As a US manufacturer and global distributor of spinal products, it has a comprehensive product portfolio that offers surgeons the intraoperative options and flexibility demanded by today's challenging surgical procedures. The company objective is to positively affect patient recovery and overall surgical outcomes by providing quality spinal products, along with excellent customer service and competitive pricing. Precision Spine is a privately held company headquartered in Parsippany, NJ, with manufacturing facilities in Mississippi. F. Taddonio, M.D., a spine surgeon with Scoliosis & Spinal Surgery and a mem- ber of the design team for the Reform® System. "The development process went through various iterations as we looked into different design parameters and ap- plied our models to cadaveric specimens to test ease of use." The developers spent hours in the lab and informal settings, shared telephone dis- cussions and reviewed designs and draw- ings 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 ad- dress the issues. "Reform® was designed with both the sur- geon and the patient in mind," says Dr. Sharma. "From the surgeon's perspec- tive, 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 ado- lescent 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 tak- ing manufacturing oversees. "We expand- ed 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 com- panies are doing well," says Mr. Pastena. "We want to be at the forefront of that." The shorter surgical times that are an- ticipated due to the Reform® System's unique design could afford several advan- tages, including: • Shorter OR times • Less blood loss • Lower cost "We are seeing a large number of sur- geons 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 per- form 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 instru- ments to fit the surgeon's preference." Future innovation Innovation in the spine field can seem in- credibly 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 sup- posed to make the patient experience bet- ter, but if the fusion rate isn't acceptable, those methods will likely need further de- velopment 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 in- sertion also lies in image guidance for pre- cision and safety. The financial feasibility of adopting new technology will also play a part in future development. Precision Spine also has a worldwide ex- clusive 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 de- signed 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. Shar- ma. "As healthcare costs are further scru- tinized, surgeons and hospitals will likely choose implants that are more cost-effec- tive than those of their competitors." n

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