Acutus Medical Announces Completion of Enrollment for UNCOVER AF™ Study of AcQMap® in Persistent Atrial Fibrillation

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

April 27, 2017

Acutus Medical , a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced that enrollment has been completed in its pivotal Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER AF) study evaluating the AcQMap® High Resolution Imaging and Mapping System in patients with persistent atrial fibrillation (AF) in Europe and Canada.

Acutus Medical notes the UNCOVER AF clinical study is a prospective, multi-center, multi-national study designed to provide clinical evidence regarding the use of the AcQMap® System in the treatment of persistent AF. The trial is being conducted at 13 sites throughout Europe and Canada and has successfully completed enrollment of 129 patients.

“We are encouraged by the rate at which we were able to enroll this study and the outcomes thus far,” said Randy Werneth, President and Chief Executive Officer of Acutus. “We believe strongly in AcQMap’s ability to address critical unmet needs in mapping AF. AcQMap enables patient specific diagnosis, treatment guidance and confirmation of the delivered treatment that is intended to greatly benefit millions of patients who, until now, face a 50/50 chance of a successful outcome after an initial ablation procedure.”

Acutus received CE Mark approval for AcQMap in May 2016 and is currently pursuing U.S. FDA clearance for the system.



Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.