FDA Approves Abbott’s Atrial Fibrillation Device to Prevent Stroke

August 19, 2021 - FDA recently approved Abbott’s device to treat individuals with atrial fibrillation (AFib) at risk of ischemic stroke.

The Amplatzer Amulet Left Atrial Appendage Occluder immediately closes the left atrial appendage (LAA), a small pouch connected to the heart’s upper left chamber. 

AFib can disrupt the heart’s ability to efficiently pump blood, which can cause blood to collect in the LAA and increases the risk for clotting. Generally, physicians look to close the LAA for patients with AFib who cannot take blood-thinning medication long term.

Abbott’s Amulet seals off the LAA entirely, reducing the patient’s risk of stroke and eliminating the need for blood-thinning medication.

“The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health and principal investigator of the study, said in the announcement. 

Prior to the approval of Abbott’s device, the only minimally invasive option for LAA occlusion is a solution with a single component to seal the LAA that required blood-thinning drugs to heal as well as additional patient monitoring.

Amulet does not require blood-thinning medication following the procedure, can treat a wide range of anatomies, and has the widest range of occluding sizes on the market, an Abbott spokesperson stated.

Michael Dale, senior vice president of Abbott’s structural heart business, added that FDA’s device approval is an important milestone in bringing a treatment option to American physicians and patients. 

FDA Approves Treatment for Von Hippel-Lindau Disease 

FDA recently approved Merck’s treatment, Welireg, for von Hippel-Lindau (VHL) disease.

The agency approved Welireg 120 milligrams for individuals with VHL disease who require therapy for associate renal cell carcinoma (RCC), central nervous system (CNS), hemangioblastomas, or pancreatic neuroendocrine tumors (pNET).  

VHL disease is a rare and serious condition. Before the approval of Welireg, there were no systemic therapies available to help treat patients diagnosed with certain types of VHL-associated tumors.

“WELIREG is the first and only approved systemic therapy for patients with certain types of VHL-associated tumors, representing an important new treatment option for patients affected by this rare condition,” Scot Ebbinghaus, MD, vice president of clinical research at Merck, said in the announcement.

“Today’s approval of WELIREG is a significant milestone and is a testament to Merck’s commitment to bring forward innovative new treatment options for more patients,” Ebbinghaus continued. 

FDA based its approval on results from the open-label Study 004 trial. In the trial, a major efficacy endpoint was the overall response rate in patients with VHL-associated RCC.

Currently, Merck is working to boost the production of Welireg to allow for sustainable supply and meet anticipated US demand. Commercial supply is expected to be available in early September.

FDA OKs Avita Medical’s Request to Amend Single-Arm Trial Design

FDA recently approved Avita Medical’s request to amend the pivotal clinical trial of its vitiligo treatment to a streamlined single-arm trial design. 

The new single-arm design will evaluate the safety and effectiveness of the company’s RECALL System for the repigmentation of stable vitiligo lesions in 23 subjects at 15 clinical sites versus the previously approved 3-arm study of 84 subjects. 

Avita Medical’s based its decision on data from other research efforts, which suggested that meaningful clinical performance differences between the three cell suspensions in the initial trial design are uncertain. 

Specifically, nearly 11 peer-reviewed publications and the treatment of over 1,000 patients outside the US have shown a high incidence of repigmentation with RECELL treatment. 

“The design change allows this program to progress in a timely and cost-effective manner toward bringing a novel therapeutic option to an underserved population,” Mike Perry, MD, chief executive officer of AVITA Medical, said in the announcement. 

“The program is on track, and we continue to believe we could be in a position to enter the US market with the vitiligo indication, following successful completion of the clinical trial, as early as the second half of calendar year 2023,” Perry continued.