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.
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.)
SCAI/ACC/AHA 2021 Guideline Update
Finding
Radial-first is Class I, Level A. Guidelines stress minimizing RAO and recommend patent hemostasis techniques.
Relevance
Positions SĀPH as guideline-aligned.
SĀPH Value
First device purpose-built for consistent patent hemostasis.
(Lawton JS et al. J Am Coll Cardiol. 2022;79:197–215.)
FUTURE - Brazil 50-Patient Clinical Study (Ongoing, 2025)
Design
Prospective trial comparing SĀPH vs. TR Band; FDA-predicate study.
Relevance
Generates comparative RAO, comfort, and workflow outcomes vs. standard of care.
SĀPH Value
Will demonstrate head-to-head benefits in real-world patients.
(Transradial Technologies Clinical Trial – São Paulo, Brazil, 2025.)
Pancholy et al., 2012 – PROPHET Trial
Finding
Patent hemostasis reduces RAO by ~60% at 24h and ~75% at 30 days vs. conventional compression.
Relevance
Validates the principle SĀPH uses: maintain flow during closure.
SĀPH Value
Reproducibly delivers patent hemostasis in a simple, consistent way.
(Pancholy SB et al. Catheter Cardiovasc Interv. 2012;79:78–81.)
First-in-Human Feasibility Study (Internal Data, 2025)
Finding
17 patients, 100% successful closure, no device-related complications.
Relevance
Early confirmation of safety and feasibility.
SĀPH Value
Proof of concept that suction-based, flow-preserving closure works in humans.
(Transradial Technologies internal feasibility data, 2025.)