Vascade MVP is a vascular closure system designed for operations requiring venous closures at multiple access sites. According to the Boston-based company, it uses 6 to 12 Fr inner diameter sheaths that are routinely used in cardiac electrophysiology operations to enable earlier ambulation, earlier discharge eligibility, and improved patient satisfaction.

CEO and President Chris Simon, in a news release, said that COVID has enhanced the need to improve safety and efficacy in order to effectively enhance the patient experience. Vascade MVP is the first and only indication for same-day discharge for atrial fibrillation ablation patients demonstrating their industry leadership and ongoing commitment to raising healthcare standards.

The Haemonetics first trial, called Same-Day Discharge (SDD) -1, was a multi-center retrospective study that enrolled 497 patients across four U.S. centres. The second study, called Same-Day Discharge (SDD) -2, was a prospective, multi-center, single-arm investigation. It included 151 individuals with paroxysmal AF from eight different institutions in the United States. The company's most recent Ambulate SDD -2 research included 203 patients with persistent AF who were included in a multi-centre, prospective, single-arm study.

Their research revealed that in retrospective study, 99.4 % of participants treated for AF with venous closure with the Vascade MVP were discharged the same day with no further intervention; in SDD -1 , 98.6 % of patients treated for paroxysmal AF with venous closure using the Vascade MVP were discharged the same day and did not require any further treatment; and in SDD -2, 99.5 percent of participants treated for persistent AF with venous closure using the Vascade MVP were discharged the same day and did not require any further treatment.

Each trial found vascular access safety identical to the Ambulate pivotal study, which found no significant access sites related complications.

In 2022, their company will begin enrolling people for the SDD -3 study, a multi-centre prospective registry with 300 participants.

Conclusion

Principal investigator on the study Zayd Eldadah concluded that the SDD clinical research investigators achieved reproducible, consistent, and durable vascular closure after AF ablation utilising Vascade MVP, enabling same-day discharge.

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Keywords

atrial fibrillation,arrhythmia,transcatheter therapy,ablation

Source

https://www.massdevice.com/haemonetics-wins-fda-nod-for-same-day-discharge-following-afib-ablation-using-vascade-mvp/

Tags

Disease Condition ,Therapeutic Modality ,Arrhythmias,Interventional Cardiology,Atrial Fibrillation,Trans catheter Therapy ,TINC_others