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Teleflex to Showcase its Interventional Portfolio Highlighting the MANTA® Vascular Closure Device and the Langston® Dual Lumen Catheters at the PCR London Valves 2019
The CE Marked MANTA® Vascular Closure Device is the first commercially available biomechanical vascular closure device specifically designed for closure of large bore femoral arteriotomies following procedures utilizing devices or sheaths ranging in size from 10F to 18F (with maximum outer diameters up to 25F). In the SAFE MANTA® IDE Clinical Trial, the IDE-defined major complication rate occurred in 5.3% of patients and VARC-2 major vascular complication rate occurred in 4.2% of cases. This VARC-2 rate is lower than published rates for suture-mediated closure. (1,2,3,4)
Langston® Dual Lumen Catheters are angiographic catheters with a two-lumen coaxial design which enables simultaneous pressure measurements across the aortic valve. The precise pressure obtained using Langston® Pigtail catheters help clinicians compute the pressure gradient and subsequently the effective orifice area.
Clinicians worldwide rely on the quality and proven clinical utility of our interventional portfolio.
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Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the
References:
1. Wood D, et al. Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA® Percutaneous Vascular Closure Device: The SAFE MANTA® Study. Circulation: Cardiovascular Interventions. 2019 July. Vol 12, Issue 7.
a. Major complications defined as composite of i) vascular injury requiring surgical repair/stent-graft; ii) bleeding requiring transfusion; iii) lower extremity ischemia requiring surgical repair/additional percutaneous intervention; iv) nerve injury (permanent or requiring surgical repair); and v) infection requiring IV antibiotics and/or extended hospitalization
Study sponsored by
2. Généreux P, et al. Vascular complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Sept 18;60(12):1043-1052.
3. Lauten A, et al. Percutaneous left-ventricular support with the Impella 2.5®-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013 Jan;6(1):23-30.
4. Data on file at
Source:
Treasurer and Vice President, Investor Relations
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Source: Teleflex Incorporated