Acutus Medical receives FDA clearance for AcQGuide Steerable Sheath

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Acutus Medical has announced the FDA clearance of the AcQGuide Steerable Sheath, which marks the first US regulatory milestone for the company. The AcQGuide Steerable Sheath is a percutaneous catheter introducer designed to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chambers of the heart.

Acutus is currently pursuing FDA clearance for the AcQMap High Resolution Imaging and Mapping System, including the AcQMap 3D Imaging and Mapping Catheter. Both products received CE mark in May 2016.

Heart Rhythm Society meeting Acutus Medical participation

Acutus Medical also announced a series of talks scheduled to be presented at the Heart Rhythm Society’s 38th Annual Scientific Sessions (10‒12 May, Chicago, USA).

Stephan Willems of University Heart Center, Hamburg, Germany will present initial results of the international DDRAMATIC SVT study evaluating the AcQMap system in patients with supraventricular tachycardia on 12 May at 14:00 CT.

A total of six additional presentations will be featured at the meeting highlighting the use of ElectroFunctional procedures in patients with both atrial fibrillation and supraventricular tachycardia.

Details of Acutus’ oral and poster presentations are as follows:

Date: May 11, 2017
Time: 9:30 AM CT – 12:00 PM CT
Title: “New Insights Into Persistent Atrial Fibrillation with the AcQMap® Dipole Density Mapping System”
Poster Number: C-PO02-68
Presenter: Arian Sultan, M.D., University Heart Center Cologne, Dept. of Electrophysiology, Cologne, Germany
Location: EPicenter, Exhibit Hall

Date: May 11, 2017
Time: 9:30 AM CT – 12:00 PM CT
Title: “Feasibility of Using An Intracardiac Mapping and Ultrasound Imaging Catheter to Estimate Left Atrial Volume”
Poster Number: C-PO02-73
Presenter: Derrick Chou, PhD., Acutus Medical Inc.
Location: EPicenter, Exhibit Hall

Date: May 11, 2017
Time: 2:00 PM CT – 5:00 PM CT
Title: “First-in-Man Biatrial Dipole Density Mapping of AT Arising during Ablation of Persistent AF: An Iterative Strategy of Electrofunctional Mapping and Ablation”
Poster Number: C-PO03-70
Presenter: Rui Shi, M.D., Ph.D., Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
Location: EPicenter, Exhibit Hall

Date: May 12, 2017
Time: 2:00 PM CT – 5:00 PM CT
Title: “Electro-Functional Ablation Procedures: Initial Results from DDRAMATIC SVT”
Poster Number: C-PO05-71
Presenter: Stephan Willems, M.D., Ph.D., University Heart Center, Hamburg, Germany
Location: EPicenter, Exhibit Hall

Date: May 12, 2017
Time: 2:00 PM CT – 5:00 PM CT
Title: “Dipole Density Versus Voltage-Based Mapping in Atrial Fibrillation: What Can Be Uncovered?”
Poster Number: C-PO05-85
Presenter: Atul Verma. M.D., F.R.H.S., Southlake Regional Health Centre, Newmarket, Ontario, Canada
Location: EPicenter, Exhibit Hall

Date: May 12, 2017
Time: 2:45PM CT – 3:00PM CT
Title: “Use of Novel Global Ultrasound Imaging and Continuous Dipole Density Mapping to Guide Ablation in Macro-Reentrant Tachycardias
Session Number: C-AB32-06
Presenter: Claire Martin, Ph.D., M.R.C.P., Barts Heart Centre, London, United Kingdom
Location: Room 181

Date: May 13, 2017
Time: 9:30 AM CT – 12:00 PM CT
Title: “Mapping Stability with Ultrasound-Based Imaging and Dipole Density Mapping in Patients with Persistent Atrial Fibrillation”
Poster Number: C-PO06-45
Presenter: Jana M. Nuhrich, M.D., University Heart Center Hamburg, Germany
Location: Skyline Ballroom Foyer – Level 3

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