Teleflex Announces Publication of “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device”
The study demonstrated that, in a selected population, the MANTA™ Device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve (TAVR) replacement, percutaneous endovascular abdominal aortic aneurysm (EVAR) repair, and thoracic endovascular aortic aneurysm (TEVAR) repair devices.1 The study authors noted that open surgical closure as well as adapted small-bore suture-based pre-closure devices have significant limitations.1 The MANTA™ Device is innovatively designed to potentially reduce bleeding complications and offset other procedural costs.1a
“We created the MANTA™ Device to address a previously unmet clinical need for effective, reproducible, and safe closure of large bore femoral arterial access sites,” said
The study 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
“This published data should give physicians the confidence they need to adopt the MANTA™ Device as their large bore femoral arterial access site closure device of choice,” said Dr.
“The publication of this data reflects our ongoing commitment to invest in and provide innovations that simplify interventions,” said
About the MANTA™ Device
The MANTA™ Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.
With the MANTA™ Device, clinicians and hospitals can achieve:
- Successful large bore closure with a device that is simple to use and does not require preclosure, saving valuable time during the most delicate interventional procedures.
- Low complication rates for fast, reliable biomechanical closure with rapid hemostasis, potentially reducing costs.1a,d
- Reproducible results, inspiring confidence in achieving successful closure.1b
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
- 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.
- MANTA™ Device demonstrated a time to hemostasis of 24 seconds median time (65 seconds mean time) from deployment to hemostasis.
- Percutaneous vascular closure obtained with the MANTA™ Device without the use of unplanned endovascular or surgical intervention.
- 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
- Rate of time to hemostasis for MANTA™ Device demonstrated from deployment to hemostasis.
Study sponsored by
Teleflex Incorporatedor its affiliates.
- Généreux P, et al. Vascular complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Sept 18;60(12):1043-1052.
- 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.
- This statement reflects the personal experience and opinion of the physician.
Treasurer and Vice President, Investor Relations
Source: Teleflex Incorporated