Crosstrees Receives 510(k) for Balloon-Free Device for Treatment of Vertebral Fracture
by Chris Wiltz on October 15, 2013
Boulder,CO-based Crosstrees Medical has announced that following an IDE study, it has received 510(k) clearance its PVA Pod System for Percutaneous Vertebral Augmentation (PVA).
Boulder,CO-based Crosstrees Medical has announced that, following an IDE study, it has received 510(k) clearance from FDA for the Crosstrees PVA Pod System for Percutaneous Vertebral Augmentation (PVA). The device offers a novel approach to the common kyphoplasty procedure for treating vertebral fractures that affect an estimated 700,000 patients annually in the United States according to the National Osteoporosis Foundation and the American Association of Orthopaedic Surgeons (AAOS).
|The Crosstrees PVA Pod System performs kyphoplasty procedures without a balloon.
In a typical kyphoplasty outpatient procedure a balloon is placed into the space of a fractured vertebra and inflated to create a space that re-aligns the bone. After this space is created, bone cement (PMMA) is injected into the space to ensure the bone does not collapse again. Two big challenges for this procedure has been measuring the quantity of bone cement to use (doctors currently measure it using the volume of the inflated balloon) and protecting against bone cement leakage, wherein the cement can travel into pathways left by the bone fracture and exit the treatment site into the body. Once this leaked cement hardens can create complications such as nerve root compression and pulmonary embolism.
Crosstrees' aim is to overcome this challenges by removing the balloon from the procedure. “The concept was to control the flow of bone cement without the need for an implant device,” says company CEO Robert Scribner. He says that the IDE study came about as the company worked with FDA. “ We submitted a 510(k) to FDA in 2008 using kyphoplasty products as predicate device. At that time FDA's view had shifted and their response was to request an IDE study to be completed for their products, which is the direction FDA was moving in in the PVA space at that time.”
The study enrolled 135 patients working in the United States, China, Venezuela, and Belgium and compared patient outcomes for the Crosstrees procedure to a literature control which included vertebroplasty and kyphoplasty outcomes. Results over a 12-month follow-up showed a significant reduction in pain sores and PMMA bone cement leakage as well as a significant reduction in new fracture rates over vertebroplasty and kyphoplasty procedures.
“The crosstrees procedure is virtually the same as kyphoplasty,” Scribner explains. “The [PVA Pod System] is woven fabric with a known volume and geometry so the physician knows the amount of bone cement to be delivered. Bone cement is delivered to the fabric, which contains the bone cement during critical part of curing cycle when it is most liquid. It then becomes a bread dough-like consistency and the fabric is removed from the body, leaving only the bone cement.”
Scribner says the advantages of control over the bone cement and knowing the targeting volume make all the difference in the procedure. “We believe it will save time because there are fewer instrument exchanges and fewer steps to surgery,” he says. “When we introduce this concept of controlling bone cement it immediately makes sense to physicians. OR techs have also said the setup is faster and simpler.”
With the FDA approval, Crosstees, with the support of its VC partners, Biomedical Ventures and Rho Ventures, is making plans for a commercial launch in Q1 of 2014. The PVA Pod System is expected to be reimbursed under current PVA coding.
-Chris Wiltz, Associate Editor, MD+DI
to post comments