Definitive Closure.
Definitive Closure.
The CELT ACD System is a next generation vascular closure device providing safe, effective and reliable closure of femoral arterial access sites following catheterization procedures with 5F to 7F sheaths.1 2 3
Designed for procedural efficiency, the CELT ACD device provides rapid and complete hemostasis in anticoagulated patients without limitations in calcified vessels.1 2 3
The one-piece implant actively seals the puncture to minimize risk of late bleeding.3
This safe and effective approach to small bore arterial closure enables early ambulation and discharge, per physician discretion, to simplify workflow, transform the patient experience, and reduce overall cost of care. 3 4 5 6
REFERENCES
1Wong et al. Catheterisation and Cardiovascular Interventions; 90:756-765 (2017)
2Cahill et al. Heart; 100: A44 (2014)
3ICELT IFU (Rev 3)
4Hussain. Presentation at Charing Cross, UK. April 2019
5Economic model, Company data on file.
6Jost et al. Letter to the editor. 09.02.20. Journal of Vascular Access.
Active, sustained hemostasis
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One-piece implant actively seals the puncture to provide rapid hemostasis in anticoagulated patients1
- 96% of patients achieved hemostasis < 5 minutes, with a mean time to hemostasis (TTH) of 0.99 minutes (vs. 16.75 for manual compression, p=.032)1 2
- Does not rely on suture or clotting agents to achieve hemostasis3
- Conformable implant designed to optimize vessel wall apposition and promote hemostasis in calcified arteries3 4
- Effective closure with 99.3% procedural success in clinical studies1 2
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Secure positioning in arteriotomy avoids cinching or pulling post-closure for sustained hemostasis1 2 3
- 0% late access site-related bleeding (following discharge)1 2
Early ambulation & discharge
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Rapid hemostasis enables early ambulation4 6
- Clinical use in 400 patients demonstrates a mean time to ambulation of 17 minutes (range: 5 – 25 min)4
- Published case review shows immediate ambulation is possible6
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Proven safety with a lower complication rate compared to manual compression1 2 3
- 99.3% freedom from major complication (including vascular repair, retroperitoneal bleeding, bleeding requiring ______transfusion or access site complications)
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Improves patient experience
- Less minor bruising reported, compared to manual compression or alternative closure devices, at one-week post-procedure2
Improved workflow efficiency
- Simple deployment uses procedural sheath, does not require a sheath exchange3
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No re-access restrictions3
- Implant visible under fluoroscopy and ultrasound, allowing immediate re-access1 2
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Promotes a more simplified workflow4 5 6
- Reliable closure eliminates the need for manual compression or monitoring for late bleeds
- May eliminate the need for checking ACTs post-procedure or reversing anticoagulation
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Improves throughput and may enable greater daily procedure volumes4 5
- Early ambulation may reduce time to discharge4 5 6
- Clinical use suggests time to discharge < 1 hour in OBL setting4
- Mean time to discharge was 33 min (range: 22 min - 48 min)
Elective closure of a femoral arterial puncture inter-operatively to facilitate immediate ambulation for patient to have a bowel movement, then return to the procedure room for re-access, case completion and re-closure through the same common femoral artery.
Objectives: This study compared the performance of Celt ACDVR, a novel stainless steel based vascular closure device versus manual compression for femoral arteriotomy site hemostasis in patients undergoing percutaneous coronary procedures.
Conclusions: After 6-F percutaneous invasive procedures in fully anticoagulated patients, TTH was signifi-cantly reduced in patients assigned to Celt ACDVR compared to patients managed with MC. The 30-day rates of vascular complications were similarly low in both groups. (CELT ACD Trial; NCT01600482)
BGF announces multi-million investment in Vasorum – high-growth medical device business based in Dublin Ireland
BGF – Ireland’s largest growth capital investor – has completed a €6 million equity investment in Vasorum Limited. Vasorum is a Dublin based high-growth medical device business specialising in sophisticated devices used to close arterial punctures in vascular, cardiology, radiology and neuro-radiology procedures. BGF invests in minority positions in growing businesses and aims to support and…