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FDA Panel Gives Nod to Less-Invasive Heart Valves

It isn’t often that medical device makers cheer for a competitor’s product.

But Irvine-based Edwards Lifesciences Corp. believes that any kind of positive news for less-invasive heart valves can only boost its own chances of approval.

A Food and Drug Administration device panel recommended the approval of rival Minneapolis-based Medtronic Inc.’s less-invasive heart valve.

The FDA panel, which is made up of doctors, cleared Medtronic’s Melody, a less-invasive heart valve designed to treat congenital heart disease in up to 4,000 patients a year, by a 12 to zero vote in late July. That support could help Edwards’ Sapien valve, which is in clinical trials in the U.S.

“We see the physician vote as a strong positive for Edwards,” said Sean Lavin of Lazard Capital Markets LLC in a research note.

Melody is on track to be the first transcatheter valve to receive FDA approval, although it will not be considered a full commercial approval. Medtronic is seeking a “humanitarian use exemption” for Melody because its target market is very small.

In view of the unanimous Melody vote, Lavin said, “we expect physicians to push hard to get these devices approved.”

Edwards’ Sapien less-invasive heart valve, which is sold in Europe, is in a large U.S. clinical trial with an eye toward a late 2011 or 2012 approval.

Sapien, which is inserted into a patient’s heart via a catheter, and similar products are considered the most significant development in replacement heart valves in years.

Even though Sapien wasn’t the subject of the panel’s focus, Lavin said there were several issues brought up that eventually could benefit Edwards.

The panel was concerned about the Melody valve fracturing and major failures that were discovered in Medtronic’s trials. That could delay the launch of Medtronic’s CoreValve, which is a Sapien rival.

Medtronic bought CoreValve, which was based in Irvine, for $700 million earlier this year.


Allergan’s Eye Drug

Allergan Inc., an Irvine drug maker, got FDA approval last month for Acuvail, a drug to treat pain and inflammation following cataract surgery.

Acuvail is a non-steroidal anti-inflammatory drug that blocks enzymes in order to inhibit the development of prostaglandins, hormone-like substances that are considered the primary sources of pain and inflammation following cataract surgery. Cataracts, or a clouding of the eye, are a major cause of blindness among older adults. Allergan said that more than 3 million cataract surgeries are performed every year.

Allergan expects to launch Acuvail in September.

Separately, Cowen & Co. drug analyst Ian Sanderson said in a CNNMoney.com article late last month that the stocks of several companies he follows, including Allergan, have gotten a boost from takeover talk in the first half of the year.

Allergan’s shares have risen about 25% since the beginning of the year with a recent market value of about $16 billion.


Bits and Pieces:

UCI Medical Center in Orange was selected to U.S. News and World Report’s America’s Best Hospitals list for the ninth consecutive year. Among the top 50 hospitals, the magazine ranked UCI 18th for urology care and 29th for gynecology care Hoag Memorial Hospital Presbyterian in Newport Beach said it was one of 23 winners of a quality award presented by Premier Inc., a hospital buying group with offices in San Diego and North Carolina Clarient Inc., an Aliso Viejo maker of medical testing products, said Russell Investments added its stock to its Russell 3000 index. The Russell indices are used by institutional investors to help guide their portfolios Kathleen Noll, vice president of the QSI dental division of Quality Systems Inc., an Irvine company that makes software for doctors and dentists to manage their practices, is serving as chairperson of the National Dental EDI Council, a trade group. The council promotes electronic data interchange within the dental industry Orange’s St. Joseph Health System said its home health network received an award for patient care from Avatar International, a Lake Mary, Fla.-based healthcare quality improvement consulting company Symphony Medical Inc., a Laguna Hills medical device maker, changed its name to CardioPolymers Inc. The company makes products that are placed in a patient’s heart through surgery or minimally-invasive procedures to treat chronic heart failure and mitral valve regurgitations.

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