Clinical Evidence Informing the SĀPH Value Story
SĀPH is designed to support patent hemostasis through a controlled, suction-based mechanism that approximates the arteriotomy to a soft, external seal.
The studies summarized below provide clinical context for SĀPH’s design intent, workflow approach, and initial observations related to radial artery patency.
Minor et al., 2021 (J Invasive Cardiol) – Randomized Trial of VasoStat vs TR Band
Finding
VasoStat reduced time to hemostasis by ~54 minutes, required fewer adjustments, and improved patient comfort vs TR Band. No RAO at 30 days.
Relevance
Shows focused, non-circumferential pressure improves workflow and comfort while preserving radial patency.
(Minor RL Jr et al. J Invasive Cardiol. 2021;33(2):E84–E90.)
Maqsood et al., 2023 (Circ Cardiovasc Interv) – Meta-analysis of Hemostasis Band Duration
Finding
Across 10 RCTs (4,911 pts), 2-hour banding best balanced outcomes: shorter durations increased hematomas, longer durations trended toward more RAO.
Relevance
Confirms 2-hour duration as optimal for safety and patency after radial access.
(Maqsood MH et al. Circ Cardiovasc Interv. 2023;16:e012781.)
Avdikos et al., 2017 (Cardiovasc Diagn Ther) – Review of Radial Artery Occlusion
Finding
RAO occurs in 1–10% of radial cases. Risk is linked to sheath size, inadequate anticoagulation, prolonged compression, and lack of patent hemostasis.
Relevance
Defines RAO as the most common complication of radial access and highlights prevention strategies.
(Avdikos G et al. Cardiovasc Diagn Ther. 2017;7:305–316.)
Dobies et al., 2016 (Open Heart) – Registry Analysis of Radial vs Femoral PCI
Finding
Radial access lowered bleeding vs femoral (0.9% vs 2.2%), but no difference when bivalirudin was used. Radial cases had higher radiation.
Relevance
Large registry confirms radial’s bleeding advantage is drug-dependent and highlights radiation trade-offs.
(Dobies DR et al. Open Heart. 2016;3:e000397.)