Clinical Experience

The Kiva VCF Treatment System* has been used successfully in the management of symptomatic VCFs related to osteoporosis  in Europe and Latin America. Benvenue Medical obtained certification to CE Mark the Kiva VCF System in December 2008 and the product is currently available for sale in Europe.   

Patient: 67 YO Female
Diagnosis: Multiple Myeloma
Treatment:
T-11, 3 loops of Kiva Implant, 2.4 cc PMMA
T-12, 1 loop of Kiva Implant, 0.5 cc PMMA
L-1,  4 loops of Kiva Implant, 3 cc PMMA

Single-Arm Clinical Study

60 patients have been treated in a single-arm, multi-center pilot study conducted in Latin America to evaluate the preliminary safety and effectiveness of the device. Data collection has been collected on over 50 patients having reached the one-year follow-up point.

Study Findings as of June 2011

• The procedure was well tolerated by all patients
• All patients experienced relief of fracture pain
• All patients experienced both immediate and long-term functional improvement
• There were no clinical failures, implant migrations, or re-interventions at the treated level
• The average volume of PMMA used per vertebra with the Kiva Implant was  2 cc,  approximately half the amount used in kyphoplasty and vertebroplasty cases⁽²³⁾ according to published literature
• The Kiva Implant provided excellent cement containment, resulting in only a 8% rate in cement extravasation, all of which were asymptomatic
• The subsequent fracture rate to date with the Kiva VCF Treatment System is 23.4%; this compares favorably to the subsequent fracture rates reported of 23% for conservative care and 33% for kyphoplasty⁽²⁵⁾ and 24% for vertebroplasty.⁽²⁸⁾

Patient: 74 YO Female
Diagnosis: Multiple Osteoporotic VCFs
Treatment:
L-1, 4 loops of Kiva Implant, 2 cc PMMA
L-4, 2.5 loops of Kiva Implant, 1 cc PMMA
L-5, 4 loops of Kiva Implant, 2 cc PMMA

The Kiva^® System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial

The FDA has granted approval to Benvenue Medical to conduct a clinical study of the Kiva VCF Treatment System at multiple medical centers. However, this product is not cleared or approved in the United States for any indication.  The objective of this landmark randomized controlled trial (RCT) is to evaluate the safety and effectiveness of the Kiva VCF Treatment System in comparison to balloon kyphoplasty in the treatment of vertebral compression fractures due to osteoporosis.

The primary endpoint for patient success is a composite endpoint based on:

• Reduction in pain
• Maintenance or improvement in function
• Absence of device related serious adverse events

Secondary endpoints include:

• Patient satisfaction
• Improved quality of life
• Ambulatory status
• Vertebral height restoration
• Reduction in the volume of cement per level
• Absence of implant or cement migration
• Adjacent fracture level rate

This study is registered at ClinicalTrials.gov. For more information, click on
http://clinicaltrials.gov/ct2/show/NCT01123512?term=BEN005&rank=1

If you are a physician treating patients with VCFs and would like more information about the KAST study or are a patient interested in finding a participating hospital, please contact Barbara S. Lindsay, Vice President of Clinical Affairs, at blindsay@benvenuemedical.com.

United States — CAUTION — Investigational device. Limited by United States Federal Law to investigational use.