Abbott has received a new, broad approval from the FDA for its tiny heart plug implant to help cut down the risk of stroke among people with atrial fibrillation, the most common cardiac arrhythmia.
The Amplatzer Amulet is delivered into the heart via a minimally invasive catheter and expands into a disc that quickly seals off what’s known as the left atrial appendage—a small, extraneous chamber nestled in the folds of the cardiac muscle, where blood can pool in a patient with an irregular heartbeat and form clots that could end up lodged in the brain.
Previous clinical data have shown the move can help lower the annual rate of ischemic cases by two-thirds, according to the company, with the left atrial appendage being responsible for more than 90% of stroke-causing clots in these patients.
The Amulet device first received a CE mark in Europe in 2013 and has since been approved to help treat atrial fibrillation and high stroke risk in more than 80 countries, including Canada and Australia. Abbott has taken the same approach to close up congenital defects that may leave a hole between two of the heart’s chambers, with different Amplatzer models and sizes.
In the U.S., the Amulet will compete directly with Boston Scientific’s umbrella-like Watchman device, in what’s estimated to be a $500 million market.
Following placement of the implant, the Watchman device may require the patient to begin a regimen of blood thinners for at least three months as they recover, which can carry bleeding risks. By comparison, the Amulet’s design may allow patients to skip those post-procedure medications entirely, according to Abbott.
“Amulet’s unique dual-seal approach has made it the number one [left atrial appendage] closure product in Europe, so today’s device approval by the FDA is an important milestone in allowing us to bring this treatment option to American physicians and patients,” Michael Dale, senior VP of Abbott’s structural heart business, said in a statement.
Abbott plans to present data from a head-to-head study comparing Amulet to Watchman at the end of this month, during the annual congress of the European Society of Cardiology.
Abbott has also been testing Amulet in a head-to-head study pitting it against lifetime regimens of blood thinners to reduce stroke risk. The ongoing trial aims to follow at least 2,650 patients with atrial fibrillation for two years to see if the device can serve as an alternative to long-term blockbuster drugs such as Eliquis, Xarelto or Pradaxa, which currently serve as the standard of care.
Meanwhile, a randomized study—presented earlier this year at the American College of Cardiology annual meeting—found that sealing off the left atrial appendage could result in a 42% drop in the number of ischemic strokes over nearly four years, making the pitch for combining mechanical solutions such as closure with blood-thinning drug regimens to further lower risks.
However, this trial only examined approaches taken during open surgery, such as a 10-minute detour during a separate procedure to close the appendage manually using sutures or other tools; it did not study minimally invasive techniques such as Boston Scientific’s Watchman or Abbott’s Amplatzer Amulet.