Sorin Falls on Report of Fatal Flaw in Heart ValvePhil Serafino
Sorin SpA fell the most in two years in Milan after Forbes reported that potentially fatal blockages have developed in the company’s Mitroflow heart valve when used in children.
A girl who had a Mitroflow valve died last year during a severe gastrointestinal illness, and an examination revealed that the device was severely obstructed, surgeons at Boston Children’s Hospital said in a Jan. 14 letter to the American College of Cardiology. An echocardiogram seven months before she died found no signs of blockage, according to the letter, which was reported on Forbes.com on Jan. 21.
Sorin declined 6 percent to close at 2.17 euros, giving the company a market value of 1 billion euros ($1.4 billion). The drop was the biggest since Jan. 9, 2012.
Sorin “takes this matter extremely seriously” and is working with the hospital to analyze the data, the Milan-based company said in an e-mailed statement. The valve was introduced in Europe in 1982 and cleared in the U.S. in 2007.
“There is a long experience of Mitroflow on the market and the bulk of clinical data to date shows that it’s a safe and effective valve in the adult setting,” Scott Bardo, an analyst at Berenberg Bank in London, said in a phone interview. The stock decline is an “overreaction” amid concern that the findings in children might hurt overall sales of the device, according to Bardo.
After the girl’s death, the hospital reached out to all patients under the age of 30 who had the valve implanted in a similar position for a test, according to the letter from James Lock, chairman of the hospital’s cardiology department, and Pedro del Nido, chairman of cardiovascular surgery.
The review found two more patients with severely obstructed valves because of calcification, and a fourth case in which the valve had been removed at another hospital, the doctors wrote. Sorin and the U.S. Food and Drug Administration were informed of the findings, they said.
“In the past few days, we have learned of other patients at this center and other centers who reportedly have exhibited similar findings,” Lock and del Nido wrote.
The FDA is aware of the issue and looking into it, Susan Laine, a spokeswoman for the agency, said by e-mail.
Made with cow tissue, the Mitroflow pericardial valve is used to replace damaged or diseased ones. Sorin estimated on Oct. 28 that sales might reach 15 million euros in 2013.