Cardiva Medical’s vascular closure system has met its clinical endpoints in the AMBULATE randomized pivotal trial. The Santa Clara, CA-based company’s VASCADE MVP, a vascular closure system designed specifically for multi-access venous closure following electrophysiology procedures such as arrhythmia ablation was evaluated in the study.
Results from the trial were presented at American Heart Association 2018 Scientific Sessions, held in Chicago.
AMBULATE enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the US. 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.
“The patients all have venous access sites in the groin,” John Russell, president and CEO of Cardiva, told MD+DI. “They all use larger sheath sizes than the standard closure procedures. Because most of the patients [have] atrial fibrillation they are all on uninterrupted anticoagulation drugs.”
He added, “For these procedures the standard of care is still manual compression to close between three and five puncture sites. After that the patient has to be confined to bed rest for about six to eight hours. No one has designed a closure device that has been designed specifically for this use – much less conducted a randomized pivotal trial.”
Here are is a breakdown of the results from the study.
- 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% 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% 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).
With the results, the company is now planning to get the device on the market.
“We submitted for PMA earlier this year and the interaction with FDA has gone well,” Russell said. “We would expect to launch it in the first half of 2019. That would be the expectation. We think it’s the dawn of a new era for closure for EP procedures.”