Over 700,000 patients annually are diagnosed with Vertebral Compression Fractures (VCF), or collapse of a vertebra due to trauma, osteoporosis, or benign and/or malignant lesions. According to an article that appeared in the peer-reviewed journal American Family Physician, VCF affects approximately 25% of all postmenopausal women in the U.S., with prevalence of the condition increasing with age and reaching 40% of women eighty or older. Because the aging Boomer population is now the fastest growing demographic in the U.S. population, the incidence of this age-specific condition is only likely to increase.
While VCF is a condition that can lead to severe pain, deformity, and loss of height, startlingly, fewer than 30% of those patients are treated. Kyphoplasty, a minimally invasive surgical treatment designed to treat pain from osteoporotic compression fractures and other forms of fracture (such as those caused by certain types of cancer), is the leading VCF procedure, with 10,000 surgeons trained in it worldwide.
“While Kyphoplasty is broadly accepted in the medical community, the practice has some serious shortcomings,” says Bill Christy, President and CEO of AOI Medical, Inc., a medical device company that is fostering new orthopaedic treatments for the spine and trauma markets. “Notably, Kyphoplasty requires two incisions into the vertebra instead of one, rarely restores height, and the procedure does not provide equal forceload distribution (allowing pressure to be spread across a larger area), thereby putting other, healthy vertebra at risk.”
AOI has pioneered a better way to treat VCF. The company’s lead product, Ascendx™, is comprised of two main instruments: a cutting device and an expandable fracture reduction device. The cutting instrument creates a cavity in cancellous (low density or “spongy”) bone into which an expandable fracture reduction device is inserted and is used to restore height by pushing on the bone walls (the hard cortical end plates) while simultaneously delivering a medical grade bone cement, uniformly filling the cavity, thereby restoring height and allowing equal forceload distribution to the vertebra.
“Recently AOI initiated a clinical trial designed to evaluate the safety and efficacy of Ascendx™, with over 90% of patients in the trial aged sixty-five or older,” explains Mr. Christy. “While all VCF procedures offer immediate pain relief, the superiority of Ascendx™ technology illustrates a decrease in secondary fractures and unprecedented instances of height restoration.” Pending FDA approval, a commercial launch could occur towards the end of 2009.
“The AOI product provides a good possibility to reproduce full anatomic reduction through single pedicle access,” says Dr. John Shiau, a surgeon at Staten Island University Hospital in New York who has been involved in recent clinical trials. Agrees Dr. John Hsiang of Seattle’s Swedish Hospital, “I like the single pedicle access which allows a less invasive surgical approach thereby reducing any potential damage or risk and minimizing trauma to the patient.”
Source: AOI Medical, Inc.