Cardiva Medical Announces Publication of Data from the AMBULATE Pivotal Study

Cardiva Medical, Inc., an innovator in the field of vascular closure, announced that positive results from the AMBULATE pivotal study demonstrating the safety and efficacy of the company’s VASCADE® MVP Venous Vascular Closure System compared to manual compression were published online in the Journal of the American College of Cardiology: Clinical Electrophysiology. The company also announced that it has received CE Mark certification in Europe for VASCADE MVP. In both the U.S. and Europe, VASCADE MVP is now the first and only vascular closure system designed and labeled specifically for multi-site venous closure following electrophysiology procedures.

“Publication of the AMBULATE study results in a respected peer-reviewed journal is a major milestone for Cardiva – and reinforces the value of VASCADE MVP for patients undergoing electrophysiology procedures,” said John Russell, CEO of Cardiva Medical. “Since receiving PMA approval from the FDA in late 2018, VASCADE MVP has been adopted as part of the workflow in more than 100 leading electrophysiology centers across the United States. We are thrilled with the reception from physicians, and with the results we are seeing with this technology to help patients get back on their feet faster after procedures such as cardiac ablation and left atrial appendage closure.”

The AMBULATE pivotal study is a randomized, controlled study of 204 patients across 13 sites treated with 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 significantly reduced use of opioid pain medications. Principal investigators and authors of the study include Andrea Natale, M.D., of the Texas Cardiac Arrhythmia Institute; Mintu Turakhia, M.D., associate professor at Stanford University School of Medicine; and Steve Compton, M.D., of the Alaska Heart and Vascular Institute.

“The use of VASCADE MVP is a transformative new option for electrophysiology that has demonstrated more efficient workflow in the EP lab and higher levels of patient satisfaction,” said Dr. Natale. “Manual compression is time-consuming and painful for the patient. Using this technology elevates the level of care we offer our patients by allowing them to get back on their feet safely and quickly, potentially leave the hospital earlier, and even take less opioids to relieve their post-procedural pain. The publication of these data further proves the value of this technology for both physicians and their patients.”

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 re-access for future procedures. VASCADE MVP’s multi-site access approach and size range using 6-12 Fr inner diameter sheaths is the standard in electrophysiology procedures such as cardiac ablation and left atrial appendage closure.

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. Over 400,000 devices in the VASCADE platform have been sold to date.

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

EU:

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 compared to manual compression in patients who have undergone catheter-based procedures utilizing 6-12 Fr inner diameter procedural sheaths, with single- or multiple-access sites in one or both limbs.

U.S.:

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 6-12 Fr 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., executive medical director, Texas Cardiac Arrhythmia Institute; 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).

ABOUT CARDIVA MEDICAL, INC.

Cardiva Medical, Inc. is a privately held medical device company focused on developing and commercializing innovative vascular closure technologies. Cardiva has won numerous recent awards for clinical, commercial and operational excellence – including the Shingo Bronze Medallion and the Medtech Insight Award – and is on the 2019 Inc. 5000 list of the fastest growing private companies in the United States for the second consecutive year. The company is headquartered in Santa Clara, California. For further information, visit www.cardivamedical.com and follow the Company on Twitter at @CardivaMedical.

VASCADE® and Cardiva Catalyst® and VASCADE® MVP are registered trademarks of Cardiva Medical®, Inc.

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