Medicrea announced that a surgeon in Lyon, France has performed the world's first spinal fusion surgery using customized spine cages created with a 3-D printer — its UNiD ALIF customized cages.
Here are five key takeaways:
1. The UNiD ALIF intersomatic anatomical inter-body device was developed by Medicrea from a 3-D digital file created from the extraction and treatment of preoperatory scanner images of the patient, a process developed internally by the company's research and development teams. The cages are made of polyetherketoneketone and exactly reproduce the anatomic details of a patient's vertebral plates.
2. The world's first procedure performed using the UNiD ALIF cages was performed by Vincent Fiere, MD, at the Hospital Jean Mermoz in Lyon, a center focused on the diagnosis of severe spinal deformities and their surgical treatment. "The intersomatic cage, specifically 'printed' by Medicrea for my patient, positioned itself automatically in the natural space between the vertebrae and molded ideally with the spine by joining intimately with the end plates, despite their relative asymmetry and irregularity," said Dr. Fiere.
3. Medicrea's UNiD platform is versatile. Earlier this year, the company launched the UNiD patient-specific spinal osteosynthesis rod system in Europe. The customized rods are pre-contoured using x-rays and proprietary software for surgeons to perform a more precise procedure for each patient.
The company also received 510(k) clearance from the U.S. Food and Drug Administration in December 2013 for it Pass LP Spinal System for the treatment of adolescent idiopathic scoliosis.
4. Medicrea reported annual sales of $31.1 million in 2013 and a net profit of $544,260. According to the company's latest financial report, "While Medicrea will continue investing in research and development proportionally to its growth, a substantial portion of the resources from its development in the United States will be allocated, in a more aggressive manner, to the opening of at least one new subsidiary in Europe (Germany), as well as arranging distribution agreements in Asia, the Middle East and Eastern European countries."
5. According to a GlobalData report, the spinal fusion market growth will be slow. While the number of spinal fusions has increased 77 percent from 2002 to 2011, according to the Agency for Healthcare Research and Quality, there is great pressure to perform fewer spinal fusions than in the past, and the number of procedures will be hindered by reimbursement changes. The compound annual growth rate will decrease from 10 percent to 5 percent through 2020, the report predicts.
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