Prominent medical-device maker Medtronic (MDT 0.62%) was a hit on the stock exchange Thursday. The company's share price rose by nearly 2% following regulatory approval of an important new product. The stock's trajectory was higher than that of the S&P 500 index, which closed the day 0.3% higher.
PulseSelect PFA System wins FDA approval
After market close on Wednesday, Medtronic announced -- no doubt happily -- that the U.S. Food and Drug Administration (FDA) approved the product. This is the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of paroxysmal and persistent atrial fibrillation (AF) -- i.e., irregular heart rhythm (also known as arrhythmia). The condition often leads to stroke or heart failure.
This approval is historic on our shores as it marks the first time a PFA device has been given the green light by the FDA. The technology uses electric pulses to induce scarring on the heart's interior, which helps to interrupt the electrical signals that produce arrhythmias.
In its press release trumpeting the regulatory win, Medtronic quoted its president of the cardiac ablation solutions business Rebecca Seidel as saying, "It's a major step toward fulfilling our vision of providing disruptive electrophysiology solutions for patients."
Medtronic aims for commercialization in early 2024
Medtronic isn't wasting any time getting PulseSelect to the market. In its press release, the medical-device company said that commercialization of the product will begin early next year.
It's likely to win significant business. The company pointed out that AF affects 60 million people around the world. With the only PFA offering on the market, the company should be able to reach more than a few people suffering from the affliction.
