Up to 15 French arterial cannula — traditionally requiring 48 hours of manual compression or costly suture‑based devices. Now, focal ball‑and‑bowl compression achieves reliable hemostasis in <24 hours, preserving perfusion and eliminating foreign material.

Venoarterial extracorporeal membrane oxygenation (VA‑ECMO) requires arterial cannulas typically 15–19 French (5–6.3 mm outer diameter). Decannulation creates a femoral arteriotomy that demands reliable closure. Current options carry significant trade‑offs:

 • Manual compression — requires 30–45 minutes of direct hand pressure followed by 12–48 hours of bed rest with a compression bandage. Failure rates are high; up to 71% require additional femoral compression devices, and 12% proceed to surgical repair1.
 • Suture‑mediated closure (Perclose ProGlide) — two-device “preclose” technique reduces open surgery but leaves nonabsorbable sutures, carries risk of infection, suture entanglement, and vessel stenosis. Vascular surgery still needed in 2% despite device use1.
 • Plug‑based devices (MANTA) — designed for TAVR, limited data in ECMO; risk of toggle dislodgement, pseudoaneurysm, and residual stenosis2.

Scherer et al. (2022): In 180 VA‑ECMO patients, manual compression required femoral compression device (FemoStop) in 71% of historical cohort vs. 39% in contemporary suture‑device cohort. Surgical intervention was 11.5% vs. 2.0% — a clear trend but with persistent morbidity.

The belief that large‑bore arterial punctures require intravascular devices or prolonged manual pressure is based on inadequate compression tools — not physiological impossibility. FEMO‑SUPERBOWL™’s spherical point compression changes the equation.

Vascular closure devices (VCDs) have evolved to address large‑bore access, but they introduce their own morbidity:

 • Foreign body reaction: Polypropylene sutures remain permanently, risking infection, granuloma, and late stenosis. Inflammatory response may compromise future access.
 • Vessel narrowing: Preclosure with two ProGlide sutures can reduce femoral artery diameter by up to 20%, limiting options for repeat interventions.
 • Failure modes: Suture entanglement, inadequate tissue capture, or calcified plaques prevent deployment in 5–10% of cases, requiring bailout surgery.
 • Infection risk: Retained suture material in immunocompromised ECMO patients carries heightened infection risk — a concern echoed in multiple registries.

Tu & Tremmel (2008): “Manual compression has long been considered the standard of care, having changed little despite 5 decades of technological advancement. VCDs have not clearly reduced bleeding complications… [and] retained foreign material may paradoxically increase the severity of complications due to risk of vessel thrombosis and infection.”