The rapid growth of efforts to alleviate lower back pain is driving innovation in surgical procedures, and in at least one case creating new opportunities for engineering plastics.
|PEEK fusion cage implant. (Solvay)|
As many as 240,000 lumbar spinal fusion procedures will be performed in the United States in 2013, representing a market of more than $3 billion.
TranS1 Inc. (Raleigh, NC), which designs and markets products to treat degenerative conditions of the spine affecting the lumbar region, is using polyetheretherketone (PEEK) in a lumbar fusion cage implant in its recently developed VEO Direct Lateral Access and Interbody Fusion System.
VEO is a direct lateral fusion system for the lumbar spine whose interbody cage is made from Zeniva PEEK rod stock. Zeniva is part of Solvay's line of Solviva Biomaterials, which was launched at K 2007. The line represents Solvay's increased emphasis on boosting penetration to the medical market with specially qualified and manufactured engineering plastics for injection molding, extrusion, and machined shapes and forms.
According to Solvay, Zeniva PEEK has a modulus that is close to that of bone, and also offers very good toughness and fatigue resistance. TranS1 is available in widths of 17-mm and 22-mm and lengths from 40-mm to 60-mm. Implants are often machined from standard shapes because of low volume requirements for specific sizes.
The implant has a large center channel to allow bone growth through the device, fusing the adjacent bony surfaces of the vertebrae.
According to the company's Web site: "The VEO Lateral System brings clear and direct visualization to lateral fusion surgery. Through a combination of direct psoas (a muscle) visualization and clear lateral fluoroscopic views, VEO is intended to let surgeons focus on the patient, not the product."
The PEEK implants contain five tantalum markers for fluoroscopic visualization. The large center channel can be easily seen.
Machined PPSU component
Radel polyphenylsulfone (PPSU) is also used for a tubular retractor designed to prevent soft tissue intrusion. PPSU was chosen for it strength, high thermal performance, chemical resistance, and ability to withstand repeated steam sterilization. The retractor is made from 50-mm diameter rod stock in lengths of 100-mm, 120-mm, and 140-mm.
The goal of fusion operations such as those done by TranS1 are to ease lower back and leg pain by removing diseased disc material and permanently joining together two or more opposing vertebrae. This is accomplished by restoring the appropriate space between the vertebrae surrounding the degenerative
TranS1 was founded in May 2000 based on concepts developed by Dr. Andy Cragg, an interventional radiologist in Minneapolis and an engineer named Bob Assell. The company had revenues of $14.6 million last year and an operating loss of $29.7 million. The company's accumulated deficit through the end of last year was $138.8 million
In an earnings press release this month, CEO Ken Reali said: "In the fourth quarter we made significant
|Tubular extractor made with PPSU. (Solvay)|
progress on our key operational goals, including further reimbursement progress, expanding clinical publications and driving adoption of the VEO direct lateral system... We believe that the stabilization of our domestic business and the initial stocking order in China have created positive momentum for TranS1 as we enter 2013."
It often takes a while to convert surgeons to new approaches and to receive backing from regulatory authorities and insurance companies. At times, companies like TranS1 are competing against physician-owned distribution companies that have a vested financial interest in certain proprietary products.
In its annual 10K statement issued this month, the company stated: "We believe that the overall escalating cost of medical products and services has led to, and will continue to lead to, increased pressures on the healthcare industry to reduce the costs of products and services. We cannot assure you that government or other third-party payors will cover and reimburse our procedures in whole or in part in the future or that payment rates will be adequate."
Several other companies are also developing improved technologies to deal with lower back pain.
They include Medtronic Sofamor Danek, Johnson & Johnson DePuy Spine, Stryker Spine, NuVasive, Zimmer Spine, Synthes, Orthofix International, Globus Medical and Alphatec Spine.
TranS1 currently outsources manufacturing, but may develop its own machining and other capabilities as it grows. It had 89 employees at the end of last year.
Its stock price on NASDAQ was $2.25 this morning, less than half its value five years ago.