New FDA Approved Arrhythmia Surgical Technology

by | Jun 24, 2021 | FDA, Healthcare, Medical Devices, Quality

Cardiac arrhythmias have a substantial impact on the cardiovascular health of those affected, however, if diagnosed and treated properly most people can carry on with a normal life. With recent advancements in medical technology, there has been a vast improvement to both diagnostic and therapeutic procedures resulting in significant progress.

Acutus Medical Inc. has officially earned FDA approval of their AcQCrossTM family of universal transseptal crossing devices. This innovative transseptal puncture system is the first of its kind to universally pair and mate seamlessly with Acutus Medical’s family of sheaths in addition to sheaths sold by other approved manufacturers1. In the United States alone, there are over 300,000 electrophysiology and structural heart procedures that rely on transseptal crossing devices each year1.

The underlying engineering behind these devices focuses on the critical requirement of accessing the left atrium inside the heart by crossing the septum. Most structural heart procedures like atrial appendage closure device implants, percutaneous mitral valve repair, and any atrial fibrillation or left-sided tachycardia ablation all need transseptal crossing devices for crucial access to the left atrium1. Venturing into the left atrium is not the only parameter incorporated into these devices, as the proper septum crossing angle and location of the septum crossing play influential roles in terms of procedure efficiency. The added benefit of being easily repositioned without catheter withdrawals and exchanges now eliminates the need for guidewire and needle exchanges1.

Class III devices such as the AcQCrossTM family of universal transseptal crossing devices can be quite extensive in terms of complying with the long list of federal regulations and strict quality standards. The team at EMMA International has rich knowledge backed by a proven track record of helping strategically navigate the unsettling journey of attaining FDA approval for a Class III medical device. Trust the experts at EMMA International to expedite any need with quality, regulatory, or compliance aspects of your product. Contact us at 248-987-4497, or email info@emmainternational.com today!

1Surgical Robotics Technology (2021) Acutus Medical Receives FDA Clearance for AcQCross, Retrieved on 21 June 2021 from: https://www.surgicalroboticstechnology.com/news/acutus-medical-receives-fda-clearance-for-acqcross/

Zach Nies

Zach Nies

Quality Engineer (Co-Op) - Mr. Nies has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Nies is completing a Bachelor of Engineer degree in Biomedical Engineering from Wayne State University.

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