SANTA CLARA, Calif.--(BUSINESS WIRE)--Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed and labeled specifically for multi-site venous closure – for 6-12 French inner diameter sheaths. This access site approach and size range is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.
VASCADE MVP uses a simple and proprietary delivery system to place a collagen patch on the outside of each vessel puncture site following completion of the procedure. Nothing is left behind inside the vessel, and the collagen outside the vessel wall is resorbed in a short period of time enabling reaccess for future procedures.
The approval is based on results of the AMBULATE Pivotal Trial, a 204-patient, 13-site randomized, controlled study of the VASCADE MVP System compared to standard manual compression following cardiac ablation. The study showed significant improvements in time to ambulation, total post-procedure time and time-to-discharge eligibility, as well as improved patient satisfaction scores and reduced use of opioid pain medications. Results of the trial were presented at the 2018 AHA Scientific Sessions by Andrea Natale, M.D., co-principal investigator and executive medical director, Texas Cardiac Arrhythmia Institute in Austin, Texas.
“We are at the dawn of a new era now for electrophysiology procedures with this trailblazing technology,” said Suneet Mittal, M.D., director of electrophysiology and medical director of The Snyder Center for Comprehensive Atrial Fibrillation at The Valley Hospital in Ridgewood, New Jersey. “The improvements we have seen in both patient satisfaction and more efficient hospital workflow make this one of those rare new technologies that produces benefits for all stakeholders.”
“With the VASCADE MVP device, we have been able to get patients safely on their feet hours earlier than previously possible after an ablation for atrial fibrillation or a left atrial appendage closure procedure,” said Amin Al-Ahmad, M.D., electrophysiologist at Texas Cardiac Arrhythmia Institute. “In our practice the new Cardiva workflow has freed up staff and beds – and patient satisfaction has skyrocketed with less time spent immobilized on their backs. This new workflow may also make it possible to send more patients home the same day as their procedure.”
“Approval of the VASCADE MVP System marks the culmination of a multi-year effort by Cardiva to pioneer the first dedicated vessel closure solution for electrophysiology procedures such as cardiac ablation and left atrial appendage closure,” said John Russell, CEO of Cardiva Medical. “We are proud to have partnered with leading EP physicians in the United States to address this unmet need – and enable patients to get back on their feet sooner and improve the workflow for these highly successful procedures. This approval – our second PMA approved product – is an exciting milestone for our team, and shipments to leading centers in the United States have already begun.”
ABOUT THE VASCADE MVP SYSTEM
VASCADE MVP is a new vessel closure device designed specifically for electrophysiology procedures and built upon the established and clinically proven VASCADE system, which has been used with over 300,000 patients.
A fully integrated, extravascular, bioabsorbable femoral access closure system, VASCADE MVP is easy to use and leaves no permanent components behind. The system combines Cardiva’s proven proprietary collapsible disc delivery system and a thrombogenic resorbable collagen patch in an integrated design.
VASCADE MVP works by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue tract and then removing the mesh disc. The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required.
VASCADE MVP INDICATIONS
VASCADE MVP is indicated for percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6-12F inner diameter procedural sheaths, with single- or multiple-access sites in one or both limbs.
THE AMBULATE PIVOTAL STUDY
The AMBULATE study was a randomized, controlled clinical trial that enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the United States. All patients had multiple (3 or 4) mid-bore (6-12 Fr inner diameter sheath) femoral venous access sites, and were randomized into one of two groups. The treatment group had all sites closed with the VASCADE MVP system, while the control group had all sites closed using manual compression, which is the current standard of care. Patients were enrolled with both radiofrequency and cryo energy sources used in their procedures. Principal investigators include Andrea Natale, M.D.; Mintu Turakhia, M.D., associate professor, Stanford University School of Medicine; and Steve Compton, M.D., Alaska Heart and Vascular Institute.
Compared to manual compression, the Vascade MVP System met all primary and key secondary endpoints, including:
- Time to Ambulation (primary endpoint). A measure of how quickly patients are able to get up on their feet and walk following vessel closure. The VASCADE MVP arm showed a median reduction of 3.9 hours (2.2 hours vs. 6.1 hours, p-value < 0.0001).
- Total Post-Procedure Time. The VASCADE MVP arm showed a mean reduction of 3.7 hours in the total time from completion of the ablation procedure to the patient walking. This was inclusive of the time to achieve vessel closure (3.1 hours vs. 6.8 hours, p-value <0.0001).
- Time-to-Discharge Eligibility. VASCADE MVP reduced the mean time for patients to be deemed eligible for discharge by 3.4 hours (3.1 hours vs. 6.5 hours, p-value < 0.0001).
- Patient Satisfaction. The patient-reported level of satisfaction with the duration of bed rest was 63 percent higher in the VASCADE MVP arm (8.3 score out of 10 vs. 5.1 out of 10, nominal p-value <0.0001).
- Opioid Pain Medications. 58 percent fewer patients in the VASCADE MVP arm used opioid-class pain medications following their procedure (15 percent of patients vs. 36 percent of patients, nominal p-value 0.001).
THE AMBULATE SERIES OF CLINICAL STUDIES
Additional studies in the industry-leading AMBULATE series include:
- AMBULATE IMPACT Study – a recently completed study that examines today’s workflow following ablation procedures with a focus on improving hospital economics through early patient ambulation and improved workflow. Results from the AMBULATE IMPACT study will be published in 2019.
- AMBULATE CAP Study – a continued access protocol study designed to evaluate the safety of VASCADE MVP with earlier hospital discharge, elimination of urinary catheters, and elimination of protamine drug use in the setting of electrophysiology procedures. The AMBULATE CAP protocol recently completed enrollment with 168 patients enrolled at three centers.
ABOUT CARDIVA MEDICAL, INC.
Cardiva Medical, Inc. is a privately held medical device company focused on developing and commercializing innovative vascular closure technologies. The Company is headquartered in Santa Clara, California. For further information, visit our website at www.cardivamedical.com and follow us on Twitter at @CardivaMedical.
VASCADE® and Cardiva Catalyst® and VASCADE® MVP are registered trademarks of Cardiva Medical®, Inc.