News | Left Atrial Appendage (LAA) Occluders | December 22, 2022

Acutus Medical Achieves EU MDR Submission Milestone in Sale of Left-Heart Access Portfolio to Medtronic

The AcQCross Qx system combines the dilator and needle needed to perform left-atrial appendage closure procedures, eliminating the need to swap equipment mid-surgery while crossing into the left side of the heart. (Pixabay)

December 22, 2022 — Acutus Medical, Inc., an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, announced that the company has achieved the second milestone under the asset purchase agreement with Medtronic of its left-heart access portfolio with the submission for CE Mark of this portfolio under European Union (EU) Medical Device Regulations (MDR). This milestone triggers a $17 million earnout payment from Medtronic to Acutus.

“We are very pleased to have achieved this important milestone ahead of schedule. This submission is a critical step in our partnership with Medtronic, and we are confident that Medtronic will be able to accelerate adoption and positive impact on patient care and physician practice,” said David Roman, President & CEO of Acutus Medical. “In addition to positioning the left-heart access portfolio for long-term success in Europe, achieving this key milestone bolsters our financial position and enables Acutus to continue to focus on our differentiated mapping and therapy platform.”

Left-Heart Access Portfolio Sale
On June 30, 2022, Acutus completed the first closing of its previously announced sale of the Company’s left-heart access portfolio to Medtronic, which includes the AcQCross septal crossing devices, the AcQGuide MINI sheath and integrated crossing device, the AcQGuide FLEX Steerable Introducer with integrated crossing device, and the AcQGuide VUE steerable sheath.

Under the terms of the agreement, at the first closing, Medtronic paid cash consideration of $50 million to Acutus for, among other things, intellectual property rights to the Company’s left-heart access portfolio and certain equipment used in the manufacturing of these products. On October 31, 2022, Acutus completed the first major milestone in this transaction with OEM qualification and has now achieved the second major milestone of EU MDR filing. Starting January 28, 2023, Acutus will be eligible to receive four years of revenue-based earnouts.

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


Related Content

News | Left Atrial Appendage (LAA) Occluders

April 4, 2024 — Osso VR, a leader in immersive procedural training, announces the release of a co-developed curriculum ...

Home April 04, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

March 18, 2024 — Conformal Medical, Inc. announced that the CLAAS System was featured in a podium presentation at the ...

Home March 18, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

January 8, 2024 — University Hospitals (UH) Harrington Heart & Vascular Institute recently became the first center in ...

Home January 08, 2024
Home
News | Left Atrial Appendage (LAA) Occluders

October 25, 2023 — ConcertAI's TeraRecon, a leader in advanced visualization and artificial intelligence (AI) for ...

Home October 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

October 25, 2023 — Findings from a trial led by Cleveland Clinic show that patients with atrial fibrillation undergoing ...

Home October 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

October 19, 2023 — Conformal Medical, Inc. announced today the one-year results from the company's CONFORMAL Early ...

Home October 19, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

September 7, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration approval ...

Home September 07, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

July 26, 2023 — Abbott is recalling the Amplatzer Steerable Delivery Sheath due to an increased risk for air emboli to ...

Home July 26, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

May 25, 2023 — Boston Scientific Corporation announced data supporting use of the company's key electrophysiology and ...

Home May 25, 2023
Home
News | Left Atrial Appendage (LAA) Occluders

May 22, 2023 — Boston Scientific Corporation announced data supporting use of the company's key electrophysiology and ...

Home May 22, 2023
Home
Subscribe Now