Regulatory Roundup: FDA clears several new solutions, including Apple’s latest AFib offering
The U.S. Food and Drug Administration (FDA) has had a busy June, overseeing a new recall for a troubled heart device and ruling that Juul’s vape products can’t be marketed or sold.
The agency also cleared multiple cardiovascular solutions in recent weeks. A quick recap:
1. Acutus Medical receives additional FDA clearance for transseptal system
Acutus Medical, a California-based healthcare technology company focused on heart rhythm issues, announced gaining FDA clearance for an updated version of its AcQCross Qx transseptal system that can be used during left atrial appendage closure (LAAC) procedures with the Watchman solution from Boston Scientific.
The AcQCross system was designed to limit the exchange of wires and needles when cardiologists are gaining access to a patient’s left atrium.
“Crossing the septum at the proper location is important when doing any left-sided heart procedure, but it can be especially critical to the success of delivering Watchman to the left atrial appendage,” Thomas Waggoner, DO, a cardiologist with Tucson Medical Center in Arizona, said in a prepared statement. “With AcQCross, I can easily reposition without withdrawing or exchanging needles or wires, so its new compatibility with Watchman has made my procedures much safer for my patients and far more efficient for me and my team.”
“The AcQCross system provides interventional cardiologists and electrophysiologists with unique benefits of broad compatibility with market-leading access sheaths while also enhancing procedure versatility and workflow,” added David Roman, interim CEO and chief financial officer for Acutus Medical. “The expanded AcQCross product line allows us to bring this innovative technology to a wider range of procedure categories that should drive sustained growth in this portfolio.”
2. Apple Watch update includes a newly approved feature for atrial fibrillation patients
When Apple previewed its watchOS 9 update in early June, one of the key features the company highlighted was a new tracking option for atrial fibrillation (AFib) patients. The AFib History feature, approved for patients 22 years and older who have been diagnosed with AFib, was designed to help users gain a better understanding of their symptoms and easily share data with healthcare providers.
“Users will also receive weekly notifications to understand frequency and view a detailed history in the Health app, including lifestyle factors that may influence AFib, like sleep, alcohol consumption and exercise,” according to a news release from Apple.
More information on the FDA clearance is available here.
3. Cardio Flow gains FDA clearance for new peripheral guidewire
Cardio Flow, a Minnesota-based medical device company, has received FDA clearance for a new stainless-steel guidewire.
The company’s FreedomFlow Peripheral Guidewire was designed to help interventional specialists tackle challenging plaque blockages in the arteries above and below a patient’s knee. Cardio Flow also announced that the new guidewire was used in a commercial case for the first time.
Jihad A. Mustapha, MD, an interventional cardiologist with Advanced Cardiac and Vascular Centers for Amputation Prevention in Michigan, performed the procedure.
“This new product has the potential to save time and costs in the endovascular lab, given its versatility in crossing occlusions and ability to deliver multiple interventional devices on a single guidewire,” Mustapha said in a statement.
4. Okami Medical receives FDA clearance for 2 vascular occluders
Okami Medical, a California-based medical device company known for its peripheral vascular solutions, gained FDA clearance for its LOBO-7 and LOBO-9 Vascular Occluders.
These two solutions, the latest offerings for Okami’s LOBO Vascular Occlusion System, give physicians new sizes to choose from when performing occlusion procedures. The LOBO-7 device was designed for vessels with a diameter of 5 to 7 mm; and the LOBO-9 device was designed for vessels with a diameter of 7 to 9 mm. The FDA had already cleared the company’s LOBO-3 (for diameters of 1.5 to 3 mm) and LOBO-5 (for diameters of 3 to 5 mm) occluders.
“LOBO represents the next evolution in vascular embolization. As opposed to coils, which rely on the formation of an irregular mass with relatively large voids to try to occlude vessels, LOBO utilizes a high density, uniform small pore structure to occlude vessels nearly instantly,” Raj Pyne, MD, an interventional radiologist at Rochester Regional Health in New York, said in a statement. “The ability to occlude vessels quickly and consistently with a single-device not only improves procedure efficiency, but also is critical and often life-saving in situations such as trauma and unstable bleeding. The smaller occluders, LOBO-3 and LOBO-5, have demonstrated excellent performance and I am excited to see the larger sizes in use.”
Prior Regulatory Roundups:
Regulatory Roundup: FDA clears 2 new devices, grants breakthrough designation to advanced AI model
Regulatory roundup: FDA clears new solutions from Boston Scientific, CathVision, Franklin Mountain Medical
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.