Bonding Material May Strengthen Vertebrae

Originally Published MDDI November 2003

R&D DIGEST

Erik Swain

An injectable synthetic biomaterial may be a better way to treat vertebral compression fractures (VCFs). Such fractures happen when vertebrae become brittle and eventually compress upon themselves.

More than 770,000 patients experience VCFs each year. Those who suffer are largely elderly women. They generally rely on “conservative care” such as bed rest, braces, and analgesics to alleviate the condition. This can take a long time and hurt quality of life. 

Orthovita Inc. (Malvern, PA) is developing a product, called Cortoss, to treat the condition more quickly and effectively. Cortoss is a high-strength, bone-bonding, biocompatible, self-setting synthetic composite. It is designed to take on the same traits as human bone when injected into the body. Therefore, when administered directly to the affected area, Cortoss can provide weight-bearing support to VCF-inflicted bones immediately.

“Immobilizing elderly women is not good for their overall health. Even after you do that, the pain may not resolve itself,” says Joseph M. Paiva, Orthovita's chief financial officer. “Instead, we can repair the problem in a procedure that is done percutaneously. It is a minimally invasive surgical procedure that is done with a needlestick through the skin. It can be done in an ambulatory- care setting or during a one-night stay in a hospital.”

The company says that while doctors sometimes use orthopedic bone cements off-label in vertebral augmentation procedures, Cortoss is the first material specifically engineered for the treatment of VCFs. Unlike some bone cements, it does not have any volatile monomers that can migrate into the body. 

Cortoss is injected by the company's catheter-based Aliquot Micro Delivery System. In September 2003, the device received a U.S. patent covering 14 separate claims. Cortoss itself received a CE mark in 2001 and is available in Europe. Two U.S. pilot studies are under way and a pivotal study is in the design phase.

The pilot studies are evaluating the use of Cortoss with two different procedures, vertebroplasty and kyphoplasty. The pivotal study will look at three patient groups: those receiving Cortoss via vertebroplasty, those receiving Cortoss via kyphoplasty, and those receiving conservative care. 

Paiva says Orthovita has been communicating with FDA on the study design. He hopes to have patients enrolled by the end of 2004 and a submission to FDA by late 2005 or early 2006. “We are hoping FDA will let us make a submission after one year of follow-up rather than two, because nothing is approved on-label for this condition,” he says.

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