The new 510(k) win paves the way for Cardiovascular Systems’ 60cm, 4 French device that comes in designs that the company says "offers a shorter shaft length, a smaller profile and a more flexible shaft than their predecessors for improved ease of use."
The Diamondback 360 devices hit the market just last fall, becoming the 1st coronary atherectomy system approved in years and giving Cardiovascular Systems access to a market estimated at more than $1.5 billion per year.
The new, lower-profile device may help physicians perform quicker operations, shorten patient recovery times and cut down on procedural complications, according to a company press statement.
The news didn’t do much for CSII shares, which dropped 1.1% by about 12:25 p.m. today, when they were trading at $33.82 apiece. The stock has lost about 1.7% since the start of the year.
Cardiovascular Systems has posted some strong news in 2014, including positive patient outcomes and cost-savings associated with its Diamondback 360, as reported from the company’s ORBIT II study. In January the company reported Wall Street-beating financials from its 2nd quarter, sending shares up nearly 20% in a single day.