Study Shows RF Kyphoplasty Procedure with StabiliT® Vertebral Augmentation System Led to 91% Less Cement Leakage

SAN JOSE, Calif.–(EON: Enhanced Online News)–DFine, Inc., developer of minimally invasive solutions for treating vertebral pathologies, announced today that Robert Pflugmacher, M.D., of University Hospital in Bonn, Germany presented 2 abstracts at the 2010 International Osteoporosis Foundation (IOF) meeting in Florence, Italy that reported his initial clinical experience with DFine’s proprietary Radiofrequency (RF) Kyphoplasty procedure to treating vertebral compression fractures (VCFs) with the company’s StabiliT® Vertebral Augmentation System.

“RF Kyphoplasty is a very safe and effective minimally invasive procedure for the treatment of osteolytic vertebral compression fractures.”

The purpose of Dr. Pflugmacher’s studies were to prospectively assess the efficacy and safety of RF Kyphoplasty compared to conventional vertebroplasty in treating painful thoracic and lumbar spinal osteoporotic fractures, as well as investigate the functional and radiographic outcomes after RF Kyphoplasty in treating painful osteolytic vertebral fractures, historically known to have a higher rate of cement leakage than osteoporotic VCFs.

The first abstract reported prospectively collected functional, radiographic and cement leakage data on 92 osteoporotic vertebral compression fractures in 60 patients treated with RF Kyphoplasty compared to 52 fractures in 39 patients treated with vertebroplasty (control group). While both procedures showed significant pain reduction and functional improvement at 3 months follow up, the study’s authors concluded that “RF Kyphoplasty resulted in the added benefits of height restoration and lower cement leakages” as shown in the table below:

* Measured as a percentage of the total patients treated. Two vertebroplasty patients had cement pulmonary embolism.

The second abstract reported 116 oncologic related vertebral compression fractures in 63 patients treated with RF Kyphoplasty. This prospective, single arm study demonstrated significant and sustained pain relief and functional improvement through 6 month follow up compared to pre-operative measurements. No symptomatic cement leakage was reported. The cement leakage rate was 4.4% per vertebra (7 vertebrae) which is less than the cement leakage rates of 10%-70% reported in the clinical literature on vertebroplasty in patients with oncologic VCFs.^1,2,3 The authors concluded, “RF Kyphoplasty is a very safe and effective minimally invasive procedure for the treatment of osteolytic vertebral compression fractures.”

“Dr Pflugmacher has presented an impressive clinical experience, demonstrating significant and sustained pain relief and functional improvement with 3 to 6 month follow up in 123 patients with osteoporotic and oncologic vertebral compression fractures treated by DFine’s unique RF Kyphoplasty procedure with the StabiliT Vertebral Augmentation System,” said Kevin Mosher, Chief Executive Officer of DFine, Inc. “Most importantly, leakage rates for the RF Kyphoplasty group, indicated we are achieving our goal of reducing complications by providing the physicians who perform these procedures with devices that enhance intra-operative control.”

About DFine

DFine, Inc., a privately held medical device company based in San Jose, Calif., is dedicated to improving patient quality of life through the development of innovative, minimally invasive therapeutic devices used to treat pathologies of the vertebrae. RF Kyphoplasty with the StabiliT® Vertebral Augmentation System is DFine’s flagship product line providing physicians greater control in the treatment of vertebral compression fractures through site and size specific cavity creation and an ultra high viscosity bone cement over an extended working time using a remotely controlled delivery system to stabilize the fracture, relieve pain and improve patient quality of life. For more information, visit www.dfineinc.com.