Healthcare Industry News: StabiliT
News Release - July 5, 2011
Study Suggests Lower Cement Leakage Rate with DFINE Radiofrequency Targeted Vertebral Augmentation(TM) (RF-TVA) in the Treatment of Vertebral Compression Fractures
SAN JOSE, Calif. & BARCELONA, Spain--(Healthcare Sales & Marketing Network)-- DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, announced the results of a study which suggests that cement augmentation using Radiofrequency Targeted Vertebral Augmentation™ (RF-TVA) with the DFINE StabiliT® System may provide a lower leakage rate than vertebroplasty and balloon kyphoplasty in the treatment of vertebral compression fractures (VCFs).“The study shows that cement augmentation using the RF-TVA technique may provide a lower leakage rate when compared to conventional vertebroplasty with high viscosity cement and standard balloon kyphoplasty,” Georgy said. “These results may be related to the unique combination of controlled delivery of an RF activated (very high viscosity) cement at a fixed flow rate after creation of multiple channels using the navigational osteotome that allows targeted cement delivery. The DFINE system also allows uni-pedicular access and remotely controlled injection to decrease the risk of radiation exposure.”
Study Overview
Cement leaks can result in neurological complications, emboli (blockages of blood vessels), or death.1 Vertebroplasty is known for its high leakage rate compared with kyphoplasty. In vitro studies showed that high-viscosity cements were shown to significantly decrease the incidence of leakage in cancellous bone-like substrates compared with low-viscosity cements. In this study, researchers performed a rigorous radiographic analysis to compare the incidence of cement leakage in cases treated with vertebroplasty using high-viscosity cement, standard balloon kyphoplasty and radiofrequency targeted vertebral augmentation (RF-TVA) using the DFINE StabiliT Vertebral Augmentation System.
Post-operative radiographs of 101 consecutive patients (151 levels ranging from the third thoracic vertebra through the fifth lumbar vertebra), were evaluated for cement leakage using a stringent diagnostic technique. Three minimally invasive techniques were evaluated: ‘high viscosity’ vertebroplasty (66 levels), balloon kyphoplasty (49 levels) and RF-TVA (39 levels). In each case optimal cement fill of the vertebral body was attempted. No leakage was reported in 69 percent of the RF-TVA group, compared to only 53 and 41 percent in the vertebroplasty and kyphoplasty groups respectively. All leaks identified were asymptomatic. This represents a significant decreased incidence of cement leakage when using RF-TVA – a 34 percent lower leakage rate than vertebroplasty, and a 47 percent lower leakage rate than conventional balloon kyphoplasty.
“This important data reinforces the benefits of minimally invasive procedures for vertebral compression fractures with RF-TVA, which combines the benefit of bone sparing, targeted cavity creation instrumentation; ultra-high viscosity cement; and an optimized delivery rate,” said Kevin Mosher, chief executive officer of DFINE. “RF-TVA is the most advanced, targeted therapy for VCFs – offering physicians more control than conventional therapies and providing patients immediate pain relief, improved quality of life, and the ability to return to daily activities.”
About StabiliT® and Radiofrequency Targeted Vertebral AugmentationTM (RF-TVA)
The DFINE StabiliT Vertebral Augmentation system is the latest advancement in the treatment of vertebral compression fractures (VCFs). During the RF-TVA procedure, a small tube is placed into the fractured vertebra and a cavity is created. Ultra-high viscosity StabiliT® ER2 Bone Cement fills the cavity and permeates the surrounding bone to stabilize the fracture. With StabiliT, physicians are able to navigate within the vertebral body to target the spinal fracture with greater precision and control, while also sparing the bone - two unique benefits of RF-TVA over older, conventional therapies such as balloon kyphoplasty. The RF-TVA procedure typically takes 30-40 minutes to complete under local anesthesia. Patients report significant and lasting back pain relief, significant improvement in mobility and quality of life, and often return to daily activities soon after the procedure.2-4 Patients can go home the same day or the following day. RF-TVA is a safe, proven and effective procedure that presents low-risk and a significant benefit for the patient.* DFINE received 510(k) clearance and commercially introduced the StabiliT system in 2008.
About DFINE, Inc.
DFINE is dedicated to relieving pain and improving the quality of life for patients suffering from vertebral pathologies through innovative, minimally invasive therapies. DFINE’s devices are built upon an extensible radiofrequency (RF) platform that presently covers two procedural applications. The first application, the StabiliT® Vertebral Augmentation System and StabiliT® ER2 Bone Cement, harnesses the power of radiofrequency energy to repair fractured vertebrae.* The company has received FDA 510(k) clearance for a second application, the STARTM Ablation System, for the treatment of spinal tumors. The STAR system will be commercially available later this year. DFINE is based in San Jose, Calif. and is privately held. For more information visit www.dfineinc.com
* As with all medical treatment options, there are risks associated with the procedure. For a complete list of potential complications and to determine if you are candidate for RF-TVA, please consult a physician. Procedure results may vary from patient to patient.
1-4 For a description of procedure risks and a complete listing of clinical references, please visit the DFINE newsroom.
Source: DFINE Inc
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