Teleflex to Showcase its Peripheral Intervention Product Portfolio Highlighting the Arrow® OnControl® Powered Bone Access System and the MANTA™ Vascular Closure Device at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2019
As the interventional cornerstone of
The CE Marked MANTA™ Vascular Closure Device is 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). The SAFE MANTA IDE Clinical Trial demonstrated that the median time from deployment to hemostasis was 24 seconds (65 second mean time).1a Technical success was achieved in 97.7% of patients, and a single device was deployed in 99.6% of cases.1b The IDE-defined major complications1c, the primary safety end point for the study, occurred in 5.3% of patients and
- Vertebral Augmentation on
Tuesday, September 10(VA-HDT 1 from 09:30 to 11:00 & VA-HDT 2 from 12:30 to 14:00) where we will showcase our OnControl® System
- A closer look at closure devices on
Saturday, September 7(CD-HDT 1 from 09:30 to 11:00 & CD-HDT 2 from 12:30 to 14:00) where we will showcase the MANTA™ Vascular Closure Device
Clinicians worldwide rely on the quality and proven clinical utility of our peripheral intervention portfolio.
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
VectorFlow is a trademark or registered trademark of
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. MANTA™ Device demonstrated a time to hemostasis of 24 seconds median time (65 seconds mean time) from deployment to hemostasis.
b. Percutaneous vascular closure obtained with the MANTA™ Device without the use of unplanned endovascular or surgical intervention.
c. 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.
Treasurer and Vice President, Investor Relations
Source: Teleflex Incorporated