News | EP Lab | April 14, 2021

FDA Clears Acutus Medical AcQCross Suite of Transseptal Crossing Devices

Product family targets electrophysiology and structural heart procedures

The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. 

April 14, 2021 — The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. 

In the United States, there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices.[1,2,3] The company will initiate its full U.S. commercial launch of AcQCross in the coming weeks.

Crossing the septum to gain access to the left atrium of the heart is a critical and required step in any atrial fibrillation or left sided tachycardia ablation procedures as well as in many left sided structural heart procedures (such as left atrial appendage closure device implants or percutaneous mitral valve repair). Achieving the proper crossing angle and location of septal crossing can significantly impact the efficiency of the entire procedure.

The new and expanded family of AcQCross catheters include versions that are length-, diameter- and tip-matched and designed to lock into the hub of sheaths now used in the vast majority of left heart procedures, including those provided by Acutus and by other vendors. This unique compatibility allows physicians to utilize AcQCross with their sheath of choice during virtually any left heart procedure.

AcQCross enables mechanical septal crossing with a spring-loaded needle that can also be enhanced with concurrent delivery of radiofrequency (RF) energy. AcQCross further streamlines procedural workflow by eliminating the need for wire and needle exchanges, as it incorporates a retained 0.032 guidewire within the hollow crossing needle.

“The elimination of guidewire and needle exchanges is an important step in facilitating transseptal crossing procedures,” said Peter Weiss M.D., MSC, director of ventricular arrythmia management and robotics, assistant professor of medicine, Banner University of Arizona Medical Center Phoenix. “The optimal septal crossing location and angle differs depending on the procedure – be it Cryoablation, RF ablation, non-contact mapping or left atrial appendage implant – so the unique ability to easily reposition without cumbersome catheter withdrawals and exchanges are benefits that cannot be overstated. As physicians, we rely on meaningful device innovation that fits into our existing procedural workflow and provides improvement. Acutus is delivering that with AcQCross.”

“This product is absolutely unique in the industry. We are giving physicians an immensely adaptable and versatile product family developed to provide an enhanced and more precise transseptal approach – and still allow them to continue to use their sheath of choice for the remainder of the procedure,” said Vince Burgess, president and CEO of Acutus Medical. “We expect that this product will be quickly and widely adopted by electrophysiologists and interventional cardiologists.”

AcQCross is now commercially available in the United States. 

For more information: www.acutusmedical.com/us/

Find more EP lab technology news

 

References:
1. 2019 Millennium Research Group: Electrophysiology Mapping and Ablation Devices | Market Analysis |US | 2019
2. American College of Cardiology – The NCDR Left Atrial Appendage Occlusion Registry
3. Transcatheter Cardiology Therapeutics (TCTMD), American Heart Association Database

 


Related Content

News | Cath Lab

May 16, 2023 — Royal Philips, a global leader in health technology, announced late-breaking data from the DCR4Contrast ...

Home May 16, 2023
Home
News | Cath Lab

March 14, 2023 — Royal Philips, a global leader in health technology, and the Gibraltar Health Authority, announced they ...

Home March 14, 2023
Home
News | Cath Lab

March 1, 2023 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for ...

Home March 01, 2023
Home
News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
News | Cath Lab
April 18, 2022 – Royal Philips and Oulu University Hospital (Finland) have announced a strategic 10-year partnership ...
Home April 18, 2022
Home
News | Cath Lab
February 16, 2022 – Fremont Bank Foundation recently donated $750,000 to its community partner, St. Rose Hospital ...
Home February 16, 2022
Home
News | Cath Lab
February 14, 2022 — A collaborative effort between The Valley Heart and Vascular Institute’s cardiology team ...
Home February 14, 2022
Home
Sponsored Content | Videos | Cath Lab

Advancements in analytics and data visualizations are helping to streamline operations and improve productivity at cath ...

Home January 13, 2022
Home
Subscribe Now