pRESET

pRESET

pRESET

Product catalog summary
Overview
The document provides detailed specifications and clinical evidence for the pRESET family of thrombectomy devices, manufactured by phenox GmbH. These devices are designed for mechanical thrombectomy procedures to treat ischemic stroke.

Specifications
The pRESET devices come in various models with different shaft diameters, working lengths, and shaft lengths. They are compatible with microcatheters of specific inner diameters and are suitable for vessels with minimum diameters ranging from 1.5 mm to 3 mm.
  • Models include PRE-4-20, PRE-6-30, PRES-5-40, PRE-LUX-4-20, PRE-LT-3-20, and PRE-LT-4-20.
  • Compatible with 0.021” and 0.0165”/0.017” microcatheters.

Clinical Evidence
The document cites studies demonstrating the efficacy of the pRESET devices in achieving high recanalization rates and favorable long-term neurological outcomes. Key findings include:
  • High success rates in recanalization (TICI 2b/3) and favorable outcomes (mRS 0-2 at 90 days).
  • Studies referenced include ARTESp, MR CLEAN, SWIFT-PRIME, EXTEND-IA, and ESCAPE.

Design Features
The pRESET devices incorporate unique design elements to enhance performance:
  • Helical slit for maintaining cell shape integrity.
  • Closed Ring Design for stable opening and wall apposition.
  • Dual Type Cell Design for deep clot integration and flexibility.

Regulatory Status
The pRESET devices have received the CE Mark (CE 0297) but are not approved for sale or use in the United States.

Conclusion
The pRESET thrombectomy devices are backed by scientific research and clinical evidence, highlighting their effectiveness in clot retrieval and patient outcomes. The document emphasizes the devices' innovative design and compatibility with various microcatheters, making them a versatile choice for medical professionals.
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Catalog excerpts

pRESET-1

Specifications When crossing profile is critical, the choice is yours FLUOROSAFE MARKER FLUOROSAFE MARKER FLUOROSAFE MARKER Shaft Working Diameter Length Microcath. diameter [inch] [mm] phenox GmbH | Lise-Meitner-Allee 31 | D-44801 Bochum | Germany www.phenox.net | Tel. +49 234 36 919 0 | Fax +49 234 36 919 19 PRESET Thrombectomy Device phenox See the pRESET in action Continuous commitment to patient care -the extended pRESET family

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pRESET-2

PRESET Thrombectomy Device Proven scientific excellence Backed by clinical evidence Dual Type Cell Design Deepest clot integration Acc. to Lamprecht S et al.3 Helical Slit LUX made visible with Closed Ring Design • safety and efficacy of mechanical thrombectomy with pRESET excellent recanalization rate • excellent long-term neurological outcome regardless of patient’s age Best-in-class clot retention and removal of red and white clot White clot Unique design elements • Helical slit maintains cell shape integrity independent of expansion diameter • Closed Ring Design ensures stable opening and...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.