Clinical evidence supporting SĀPH radial closure
SĀPH is designed to reduce radial artery occlusion (RAO) while simplifying workflow and improving patient comfort. The following peer-reviewed studies and early feasibility data support the SĀPH value story.
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.
SĀPH Value
Confirms the advantage of flow-preserving, non-compressive closure—SĀPH achieves this through suction-based hemostasis.
(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.
SĀPH Value
Eliminates uncertainty around banding protocols by achieving immediate, patent hemostasis without prolonged compression.
(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.
SĀPH Value
By preserving flow without compression, SĀPH directly addresses the key causes of RAO.
(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.
SĀPH Value
Underscores the need for safer, flow-preserving closure without added radiation—what SĀPH delivers.
(Dobies DR et al. Open Heart. 2016;3:e000397.)
Rashid et al., 2016 (JAHA) – Meta-analysis of RAO
Finding
RAO occurs in ~7.7% of cases at 24 hours with compression-based closure devices.
Relevance
Establishes RAO as a clinically significant complication of standard radial hemostasis.
SĀPH Value
Device directly addresses RAO by maintaining flow during closure.
(Rashid M et al. JAHA. 2016;5:e002686.)