Merit Medical Acquires DFINE, Inc.

SOUTH JORDAN, Utah, July 06, 2016 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has acquired DFINE, Inc. headquartered in San Jose, California, in a merger transaction through which DFINE has become a wholly-owned subsidiary…

Commercial Launch of the Long SpineSTAR® Ablation Instrument

DFINE® Announces Commercial Launch of the Long SpineSTAR® Ablation Instrument for the Palliative Treatment of Metastatic Spine Tumors SpineSTAR’s extended working length provides spine specialists greater access and ability to precisely target metastatic spine tumors in order to offer patients rapid, sustained pain relief improving their quality of life.  San Jose, Calif. (PRWEB) December 15,…

First Patients Enrolled in the STARRT Clinical Study

San Jose, Calif. January 23, 2015 — DFINE, Inc.,announced today that the first two patients have been enrolled in the STARRT Clinical Trial at Providence Sacred Heart Medical Center, Spokane WA. The multi-center trial is the first prospective study to evaluate the treatment of painful metastatic lesions with STAR Targeted Radiofrequency Ablation (t-RFA) and Radiofrequency Targeted Vertebral Augmentation (RF-TVA) prior to or following radiation therapy.

Treatment of Metastatic Spinal Lesions with a Navigational Bipolar Radiofrequency Ablation Device: A Multicenter Retrospective Study

Praveen R. Anchala, MD, Winston D. Irving, MD, Travis J. Hillen, MD, Michael V. Friedman, MD, Bassem A. Georgy, MD, Douglass, M. Coldwell, MD, PhD, Nam D. Tran, MD, PhD, Frank D. Vrionis MD, PhD, Allan Brook, MD, and Jack W. Jennings, MD, PhD

Article presented the reality of fast and lasting relief from painful metastatic lesions

Praveen study 1

Conclusions

The STAR Tumor Ablation System:

  • Was safely & effectively used in the treatment of metastatic spinal tumors
  • Allowed RFA treatment of previously untreatable lesions which resulted in reduction of pain that was not controlled with systemic or radiation therapy
  • In certain cases with posterior wall involvement, posterior extension of tumor was halted
  • Did not hinder or delay other therapies

Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Using a Targeted Bipolar Radiofrequency Ablation Device: Technical Note

Travis J. Hillen, MD, Praveen R. Anchala, MD, Michael V. Friedman, and Jack W. Jennings, MD, PhD. Hillen, et al., Radiology. 2014 June 13:131664, E-pub prior to print Pubmed ID: 24927327

 

This article presented how targeted Radiofrequency Ablation (t-RFA) with the STAR Tumor Ablation System can serve as a Minimally Invasive Solution to Safely and Effectively Treat Previously Inaccessible Spinal Lesions

Clinical STAR Metastatic RCC Case Study

Conclusions

The STAR Tumor Ablation System:

  • Provides access to tumors that are difficult to reach with conventional ablation systems
  • Allows for safe & controlled ablation of spinal tumors
  • Does not hinder or delay other therapies
  • May provide an alternate therapy for tumors that do not respond to chemotherapy or radiation therapy

 

DFINE Announces Commencement Of Clinical Study On Spinal Tumor Ablation With The STAR Tumor Ablation System

San Jose, Calif. and Magdeburg, Germany – June 11, 2014 – DFINE®, Inc., a market leader in the minimally invasive treatment of spinal diseases, today announced that the first patient has been enrolled in the EU-STAR Clinical Trial. The multi-center trial is the first prospective study to evaluate clinical outcomes in patients receiving treatment with…

New Studies Highlight Benefits Of STAR Tumor Ablation System For Patients With Spinal Tumors

San Jose, Calif. – Feb. 18, 2014 –Two studies presented at the American Society of Spine Radiology (ASSR) 2014 Annual Symposium in Miami highlighted the benefits of Targeted Radiofrequency Ablation™ (t-RFA) therapy with the DFINE STAR™ Tumor Ablation System. The studies demonstrated the ability of the STAR System to provide significant pain relief to patients…

Comparison of Radiofrequency-targeted Vertebral Augmentation with Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: 2-year Results.

Bornemann R, Jansen TR, Kabir K, Pennekamp PH, Stüwe B, Wirtz DC, Pflugmacher R. J Spinal Disord Tech. 2013 Pubmed PMID: 24247030

OBJECTIVES: Evaluation of safety and effectiveness of radiofrequency-targeted vertebral, augmentation (RF-TVA) in comparison to balloon kyphoplasty (BK) for the treatment of, acute painful vertebral compression fractures (VCF) on the basis of matched pairs.

METHODS: A total of 192 patients (116 females; 51 – 90 y) with VCF (n=303) at one to three, levels were treated with RF-TVA or BK. Functionality (ODI), pain (VAS), vertebral, height (anterior, middle) and kyphotic angle were evaluated over a two year period, (postoperatively, 3-4 d, 3, 6, 12 and 24 mo). Additionally, operating time and, occurrence of cement leakage were recorded.

RESULTS: Pain and functionality were significantly improved after both treatments. In both groups, there was an increase in vertebral height and a decrease in kyphotic angle, which, remained relatively consistent during 24 months. The incidence of cement leakage was, 9.4% (n=9) in the RF-TVA group and 24.0% (n=25) in the BK group. The mean, operating time with radiofrequency kyphoplasty was 25.9±9.9 minutes and with balloon, kyphoplasty 48.0±18.4 minutes.

CONCLUSION: RF-TVA is a safe and effective procedure for the treatment of vertebral compression, fractures when compared to BK. Improvement in pain and functional scores following, RF-TVA are durable through 24 months post-procedure and remained better than, those following BK at long term follow up. Operating time for RF-TVA is shorter and the, risk of cement leakage is lower. Both procedures provided similar results in vertebral, height restoration and reduction in kyphotic angle.