Less-invasive heart valves, which have the potential to be the biggest development in heart valves in years, took center stage at a recent European trade show.
Irvine-based Edwards Lifesciences Corp. released promising results for its touted Sapien aortic heart valve at the EuroPCS show in Spain a few weeks ago.
According to Edwards, nearly 1,100 patients who received the valve had high survival rates 30 days after implantation.
Sapien, which is inserted with a catheter that? threaded inside the body and into the heart, and other catheter valves eliminate the need for open-heart surgery and are seen as broadening the market to patients who are considered too old or too sick for major surgery.
Sapien, which is approved for use in Europe, is projected to have European sales of more than $100 million.
As for the study, Edwards said that patients who had the Sapien valve implanted through the femoral artery in the leg had a 30-day survival rate of 93.7%, while those who received the valve through a small incision in their ribs had a 30-day survival rate of 89.7%.
Edwards said the study results were better than it had predicted for the patient group, which is considered high-risk and made up of older, very sick patients.
Analyst Sean Lavin of Lazard Capital Markets called Edwards?data ?uperb, as we had anticipated.?
Edwards has an eye on U.S. Food and Drug Administration clearance for Sapien in 2011.
The approval is likely to happen if it has similar clinical trial results in the U.S., Lavin said.
Analysts have said the market for less-invasive valves could reach $1 billion a year within 10 years of their launch.
Edwards wasn? the only device maker with good news.
Medtronic Inc., which bought Irvine? CoreValve Inc. for $700 million in February in a bid to get in closer competition with Edwards, presented data showing procedural success in implanting a minimally invasive heart valve.
The data showed that inserting CoreValve through the subclavian artery, which is located under a patient? collar bone, resulted in an 89% 30-day survival rate in patients who received the valve. The data also showed 100% procedural success, as well as a 100% 24-hour survival rate.
Lavin predicts some doctors may lean toward Medtronic? device because a third of European patients can? have a heart valve implanted through the leg. But, Lavin said, Edwards?Sapien valve could be modified for use in the same subclavian implantation
technique.
Edwards is developing Sapien XT, a smaller less-invasive valve that could be inserted like CoreValve? device is.
Columnist Revisits Spectrum
Despite a big run-up in Irvine? Spectrum Pharmaceutical Inc.? stock, TheStreet.com columnist Adam Feuerstein still is hesitant about the drug maker? ability to capitalize on cancer drug Zevalin.
Zevalin is a drug used to treat non-Hodgkin? lymphoma, which is a form of blood cancer.
In a recent column, Feuerstein admits that he ?issed the boat?on recommending Spectrum before its shares took off, but he cautions it is still too early to deem Zevalin a success.
Spectrum? shares have shot up some 230% since March with a recent market value of about $160 million.
In an earlier column, Feuerstein said he was interested in watching how Spectrum performed, particularly if the FDA approved Zevalin to serve a wider range of cancer patients, a decision expected to come in July.
But Feuerstein also said he was a realist and questioned whether Spectrum could do any better with Zevalin?hich is clinically effective but has been a commercial disappointment?han its previous three owners.
Feuerstein said that he wasn? sure how to explain Spectrum? recent run.
?nsiders have been buying stock, which helps, as is a more general bump in highly speculative biotech and drug stocks recent-
ly. It? still too early to judge Spectrum? success with Zevalin.?
Bits and Pieces:
Tustin drug developer Peregrine Pharmaceuticals Inc. said last month that it completed enrollment in a second-phase clinical trial evaluating drug candidates for advanced breast cancer patients ?Exiqon Diagnostics, a Tustin-based unit of Denmark? Exiqon A/S, said it now offers KRAS mutation analysis, a diagnostic test that predicts therapeutic response in colon and lung cancer patients, in its local laboratory ?Hoag Memorial Hospital Presbyterian, Mission Hospital, UCI Medical Center, Chapman Medical Center, Children? Hospital of Orange County, Los Alamitos Medical Center and Western Medical Center-Santa Ana recently were honored for their organ and tissue donation performances by OneLegacy, a Los Angeles organ and tissue recovery organization ?Monarch HealthCare, an Irvine-based group medical practice, said it opened a senior wellness center in partnership with Garden Grove-based Nifty after Fifty, in Laguna Woods.
