Cardiva Medical Announces Positive Results of the AMBULATE Pivotal Study Evaluating the VASCADE MVP System Compared to Manual Compression for Multi-Vessel Closure Following Electrophysiology Procedures

  • The AMBULATE pivotal study met its primary efficacy endpoint. The
    median time to patients getting on their feet following arrhythmia
    ablation procedures was reduced by 3.9 hours.
  • AMBULATE demonstrated that patients in the VASCADE MVP arm had
    significantly improved patient satisfaction and a significant
    reduction in the post-procedure use of opioid pain medications.
  • Late-breaking results were presented at the American Heart
    Association 2018 Scientific Sessions.
  • The VASCADE MVP System has been submitted for PMA approval and is
    under FDA review.

SANTA CLARA, Calif. & CHICAGO–(BUSINESS WIRE)–Cardiva Medical, Inc., an innovator in the field of vascular closure,
today announced that VASCADE® MVP, the first vascular closure system
designed specifically for multi-access venous closure following
electrophysiology procedures such as arrhythmia ablation, met its
endpoints compared to manual compression in a pivotal clinical study.
The AMBULATE study is the first randomized pivotal trial of vessel
closure conducted exclusively by electrophysiology physicians.

These positive results were presented today in the Late-Breaking
Presentations section of the American Heart Association’s Scientific
Sessions by Dr. Andrea Natale, executive medical director, Texas Cardiac
Arrhythmia Institute.

“The feedback from our patients and staff was extremely positive with
VASCADE MVP during the study,“ said Dr. Natale. “Patients with previous
procedures noticed a significant improvement in their level of comfort
due to the much shorter bed rest time, and the time saved overall
enabled us to implement a new more efficient workflow in the hospital.
Additionally, there was a substantial decrease in the use of
post-procedural pain medications in patients receiving the VASCADE
device. This type of innovation will be particularly important as demand
for these procedures continues to grow.”

“VASCADE MVP and the AMBULATE pivotal study represent Cardiva’s
commitment to innovation that improves the post-procedure experience for
patients undergoing cardiac ablation,” said John Russell, CEO of Cardiva
Medical. “The impressive results reported today mark a major milestone
in that effort. We are grateful to the investigators, their research
teams, and their patients for making the AMBULATE study possible.”

Study Design

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 Dr. Andrea Natale; Dr. Mintu Turakhia,
associate professor, Stanford University School of Medicine; and Dr.
Steve Compton, 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, p-value
    <0.0001).
  • Opioid Pain Medications (ad hoc analysis). 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, 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 is currently being conducted with approval of the U.S. Food
    and Drug Administration (FDA).

About the VASCADE MVP System

VASCADE MVP is a fully integrated, extravascular, bioabsorbable femoral
access closure system that is easy to use and leaves no permanent
components behind. The system combines Cardiva’s proven proprietary
collapsible disc technology 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 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 is a new, investigational device – designed specifically for
electrophysiology procedures –built upon the established and clinically
proven VASCADE system, which has been used with over 250,000 patients.

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® are registered trademarks of Cardiva
Medical®, Inc.

Contacts

Cardiva Medical, Inc.
Sierra Smith, 408-540-4296
sierra@healthandcommerce.com

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