On 28 June, DFine announced that the first patient, a 50-year-old suffering from breast cancer, was successfully treated using the Spinal Tumor Ablation with Radiofrequency (STAR) system in a prospective clinical trial. The trial is designed to evaluate the safety and efficacy of targeted radiofrequency spinal tumour ablation and cement augmentation in patients with metastatic spinal tumours.
The AbCT trial (Evaluation of combined RF ablation and cement delivery in painful tumors of the spine), began enrolment at the University Medical Center of the Johannes Gutenberg University Mainz, Germany on 22 June 2011. The single-centre study will involve up to 10 evaluable patients.
“The results of this trial will provide critical information about the safety and efficacy of minimally invasive targeted radiofrequency ablation to treat vertebral metastases,” Andreas Kurth, professor and director of the Orthopedic Clinic at University Medical Center of the Johannes Gutenberg University in Mainz, Germany. “We are confident that DFine’s advanced methods for tumour reduction and cancellous bone-sparing augmentation will minimise the cancer patient’s severe discomfort while stabilising the vertebra.”
The STAR System incorporates a unique bipolar navigational instrument, which offers a high degree of control and enables the physician to overcome many of the technical challenges, which have limited targeted ablation in bony tissue to date. The FDA-approved device also permits minimally invasive targeted tumour necrosis of metastatic spinal tumours. Following ablation with the STAR system, vertebra(e) will be stabilised with ultra-high viscosity cement using Dfine’s compatible StabiliT Vertebral Augmentation System. This minimally invasive procedure generally takes one to two hours.
“This is the first prospective study to focus on the substantial palliative benefits of targeted tumour ablation in the interventional oncology arena involving the spine,” said Kevin Mosher, chief executive officer of DFine. “This therapeutic approach combines the company’s core technologies— radiofrequency energy, navigational instrumentation and ultra-high viscosity bone cement — into an extension of our radiofrequency platform that represents a major milestone for cancer patients and the company.”
“Due to the critical anatomy in the spine and the invasive nature of conventional surgical procedures to treat spinal metastases, we believe Dfine’s minimally invasive therapy that allows targeted delivery of radiofrequency energy for ablation of tumours may provide the fastest and most effective relief from the painful effects of spinal metastases, and thereby represents a significant advance in the treatment of these patients,” Kurth said.
DFine plans to use data from the AbCT Trial to file for Conformité Européenne (CE) mark certification in 2012.