In 2013, sales of the novel transcatheter aortic valve replacement device from Edwards Lifesciences disappointed quarter after quarter leading MD+DI to put the California heart valve company in its annual losers list.
Transcatheter heart valve replacement is an alternative to invasive open heart surgery performed to remove or repair diseased or blocked heart valves. Edwards was the first company in the U.S. to introduce its TAVR product in late 2011.
Since the failings of 2013, the company has reversed its fortunes lately and despite competition from heavyweight Medtronic.
Now, quarter after quarter, Edwards Lifesciences reports better-than-expected results of revenue from its Sapien family of transcather heart valves.
In the quarter ended Dec. 31, transcatheter heart valve revenue stood at $267.5 million, a whopping 46% increase from the fourth quarter of 2013. Even adjusting for foreign exchange fluctuations, the sales increased 38%. In the U.S. sales grew 36% to $126.4 million.
"Though [Edwards] continues to weather the launch of [Medtronic's] CoreValve in the U.S., and while the U.S. market lacks access to the intermediate risk patient population, U.S. [transcatheter heart valve] sales have exceeded expectations now several quarters in a row given a faster and more dramatic market ramp that we view as sustainable for the foreseeable future," wrote Danielle Antalffy, an analyst with healthcare investment bank Leerink Partners, in a research note Wednesday.
In an earlier research note, Antalffy declared that she believes Medtronic will only gain modest share in the transcatheter heart valve market in the U.S. in the short term.
After witnessing another stellar performance of Edwards Lifesciences, another analyst opined:
"Although [Medtronic] received approval for high-risk patients for its CoreValve system in June, it seems that [Edwards] continued to feel little impact from competitors in [the fourth quarter] in the [transcatheter heart valve] segment," wrote Gregory Chodaczek, an analyst with Sterne Agee in a research note Wednesday.
Overall, Edwards reported revenue of $618 million, up 15% from the fourth quarter of 2013. Profits climbed to $109.2 million, or $1 per diluted share, from $75.1 million, or 68 cents per diluted share.
Correction: An earlier version of this story incorrectly stated the year Sapien was approved. It was approved in November 2011