Benvenue Medical develops next generation minimally invasive expandable implant systems for the spine, supported by clinical data.
Benvenue Medical completed the KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) clinical trial to support a 510(k) filing for market clearance from the U.S. Food and Drug Administration (FDA).
The KAST trial evaluated the Kiva Vertebral Compression Fracture (VCF) Treatment System in one of the largest randomized studies in this space to date versus the current standard of care in the treatment of VCFs, balloon kyphoplasty. The primary endpoint was non-inferiority on a composite of pain, function, and safety at one year of follow-up on patients treated in the study. The study was designed to evaluate key secondary endpoints including PMMA cement volume, extravasation rate, and height restoration as well as other endpoints. The trial enrolled 300 patients at 21 medical centers in the United States, Canada, Belgium, France and Germany.
Benvenue Medical received FDA clearance to market the Kiva VCF Treatment System in the United States in January 2014. Kiva bears the CE Mark for distribution in the European Union.
The Kiva VCF Treatment System is indicated for the use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.
As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the products listed on this site. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions. Consult a healthcare provider regarding specific treatment options.
Kiva has been demonstrated to meet or exceed the performance of balloon kyphoplasty in 3 separate comparative studies.
|CLINICAL STUDIES||KEY FINDINGS|
|1. KAST: The Kiva® System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial.Design: Prospective, randomized, multi-center clinical trial to evaluate the safety and effectiveness, and support non-inferiority of the Kiva VCF Treatment System versus balloon kyphoplasty: 300 patient trial
Authors/Publication: Tutton, Garfin, et al. Spine, March 2015.
*Posterior probability of superiority was > 90%
|2. Economic Analysis of Kiva VCF Treatment System compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data Design:
Economic analysis of KAST randomized trial, focusing on medical resource use and costsAuthors/Publication: Beall, Olan, et al. In Press, Pain Physician Journal, 2015.
|3. Balloon kyphoplasty versus KIVA Vertebral Augmentation.
Comparison of two Techniques for Osteoporotic Vertebral Body Fractures. A prospective randomized study.Design: Prospective, randomized, single center study: 168 patients treatedAuthors/Publication: Korovessis, et al. Spine, February 2013.
|4. Comparison of balloon kyphoplasty with the new Kiva VCF System for the treatment of vertebral compression fractures. Design: Matched pairs, retrospective, single center study of Kiva vs. balloon kyphoplasty with Medtronic balloons: 52 patients
Authors/Publication: Otten, Pflugmacher, et al. Pain Physician Journal, October 2013.
The following are clinical publications relating to the clinical use of Benvenue Medical’s innovative products. Please check back for regular updates.
Berjano P, Damilano M, Pejrona M, Consonni O, Langella F, Lamartina C. European Spine Journal 2014, Volume 23, Issue 6, pp 1379-1380.
Comparison of balloon kyphoplasty with the new Kiva® VCF System for the treatment of vertebral compression fractures.
Otten LA, Bornemnn R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Pain Physician. 2013 Sep-Oct;16(5):E505-12.
Transpedicular vertebral body augmentation reinforced with pedicle screw fixation in fresh traumatic A2 and A3 lumbar fractures: comparison between two devices and two bone cements
Korovessis P, Vardakastanis K, Repantis T, Vitsas V. European Journal of Orthopaedic Surgery and Traumatology. 2013 Aug 28.
Percutaneous Vertebral Augmentation Assisted by PEEK Implant in Painful Osteolytic Vertebral Metastasis Involving the Vertebral Wall: Clincal Experience on 40 Patients.
Anselmetti GC, Manca A, Tutton S, Chiara G, Kelekis A, Facchini FR, Russo F, Regge D, Montemurro F. Pain Physician. 2013 Jul-Aug;16(4):E397-404.
Minimally invasive treatments for osteoporotic vertebral compression fracture: current concepts and state-of-the-art technologies.
Tutton SM, Facchini FR, Miller LE. Techniques in Regional Anesthesia and Pain Management 1 6 (2012)118–123.
Balloon Kyphoplasty versus Kiva Vertebral Augmentation. Comparison of twoTechniques for Osteoporotic Vertebral Body Fractures. A prospective randomized study.
Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Spine (Phila Pa 1976). 2013 Feb 15;38(4):292-9.
Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System.
Rosales LM, Dipp JM, Flores R, Bajares G, Perez A. SAS Journal, Volume 5, Issue 4 , Pages 114-119, December 2011.
Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients.
Korovessis P, Repantis T, Miller LE, Block JE. BMC Musculoskeletal Disorders. 2011 Sep 22;12:206. doi: 10.1186/1471-2474-12-206.