More than 40 million people in the U.S. have osteoporosis, which often results in compression fractures that cause severe back pain. Vertebroplasty and kyphoplasty are the surgical treatment options, but both require a different set of tools. CareFusion (San Diego) has just launched the AVAmax Vertebral Balloon, a minimally invasive device for use during kyphoplasty. Now it's offered in a combined kit, the only one on the market that addresses both vertebroplasty and kyphoplasty approaches.
“The kit will offer the surgeon flexibility to make decisions at the point of patient care,“ Jim Leitl, VP and general manager of medical specialties for CareFusion, told Medical Device Daily.
The new balloon is packaged in a kit that includes needles, bone cement and both vertebroplasty and kyphoplasty delivery systems giving surgeons a ready choice and flexibility to perform either procedure. The kits also allow hospitals to safely store unused components between procedures, which lowers costs and reduces waste.
Leitl estimates that the combined product will result in a 30% savings to patients.
The kit also includes an automated cement mixer. The surgeon just hits the “mix“ button to initiate an automated cycle that mixes the cement inside the mixing barrel, which signals when it is ready for patient application.
In vertebroplasty, surgeons use image guidance to inject the special cement mixture through a hollow needle into the fractured bone. In kyphoplasty, a balloon is inserted first through the needle into the fractured bone to restore the height and shape of the vertebra. Once the balloon is removed, the cement mixture is injected.
With the addition of the kyphoplasty product, Leitl said CareFusion enters a market of procedures that represents a $600 million global healthcare segment
“Stabilizing spinal fractures caused by osteoporosis through kyphoplasty or vertebroplasty is a mainstay of treatment,“ said Wade Wong, MD, professor of radiology, division of interventional neuroradiology at the University of California, San Diego. “However it may be difficult for doctors to predict which procedure to perform until they see the current state of the fracture once in the procedure room.“
When a surgeon opts for vertebroplasty, image guidance is used to inject the cement mixture through a hollow needle into the fractured bone.
The AVAmax Plus vertebral augmentation system, used with the AVAmax Vertebral Balloon to deliver cement, has features that allow the radiologist's hands to be out of the radiation field, making the procedure safer for the clinician, according to the company.
Leitl said that CareFusion has not sponsored clinical trials related to these spinal fracture repair tools.
Vertebroplasty is usually performed on people who have severe pain requiring hospitalization; are too elderly or frail to tolerate open spinal surgery, or who have bones too weak for surgical spinal repair; have vertebral damage due to a malignant tumor; or are younger and have osteoporosis caused by long-term steroid treatment or a metabolic disorder. Kyphoplasty is performed on patients with fractures from osteoporosis as well, but must occur within eight weeks of when the fracture occurred for the highest probability of restoring the spinal bone to its normal height. During a kyphoplasty, a small balloon is used to create a cavity in the vertebral body and ultimately deliver bone cement in that cavity. A vertebroplasty does not include the use of a surgical balloon to deliver the bone cement.
And while these seem like straightforward parameters, its not always clear until the time of the procedure, Leitl said.
“Adding the AVAmax Vertebral Balloon to our existing offering is another example of CareFusion's commitment to developing products that help lower the cost and improve the safety of healthcare,“ said David Schlotterbeck, chairman and CEO of CareFusion. “Our entry into the kyphoplasty market builds upon our existing leadership in vertebroplasty and provides physicians with a less expensive way to treat spinal compression fractures by reducing waste of unused components between the two procedures.“
For product commercialization, CareFusion is developing a dedicated sales force, with expansion plans in Europe next year.
“We are just starting to ship,“ Leitl said. “It's in a limited market release and will go to full market launch in May or June.“
Lynn Yoffee; 770-361-4789