Acutus Medical has received two CE marks this week for heart treatment devices and access tools and has begun their European commercial launch.
This includes a green light for a line of minimally invasive hardware that allows a cardiac surgeon to pass through the heart’s internal wall separating its right and left chambers—granting access for a range of procedures such as ablations to treat atrial fibrillation, the closure of small pouches in the muscle wall that may increase the risk of stroke, and the repair or replacement of the heart’s mitral valve.
The company’s AcQCross Transseptal System includes steerable introducers and a spring-loaded needle equipped with a dilator that gently widens the hole enough to pass through guidewires and treatment devices.
The system, which previously received clearance from the FDA, also allows the guidewire to remain in place while the surgeon repositions and exchanges tools for electrophysiology and structural heart procedures.
In the past year, the company’s transseptal crossing sales have grown steadily in the U.S., according to President and CEO Vince Burgess. “Despite the continuing COVID headwinds, we remain encouraged by adoption trends in the U.S. and, with our CE Mark now in hand, we look forward to building sales in additional geographies,” Burgess said.
RELATED: Heart-mapping Acutus Medical kicks off $158M Nasdaq IPO
Acutus also scored a CE mark for its AcQBlate ablation system—which includes a gold-tipped electrode and a sensor that measures the amount of force being applied to the heart wall in real-time, to help improve the overall safety of the procedure.
The system also incorporates two components developed through a partnership with Biotronik, including its radiofrequency generator and irrigation pump.
Together with Acutus’ AcQMap 3D cardiac imaging system, the company aims to offer a complete solution in Europe for electrophysiologic mapping and radiofrequency ablation for the treatment of abnormal heart rhythms. The AcQBlate system is not yet available in the U.S.