Minnesota medical device maker Medtronic Inc., which has about 650 workers in the county, recently got the regulatory go-ahead for a clinical trial of a new type of heart valve developed in Irvine.
Medtronic received Food and Drug Administration approval to study its CoreValve in more than 1,200 patients at 40 U.S. sites. The valve is inserted via a catheter and doesn’t require open-heart surgery.
The valve is seen as the closest rival to a similar device from Irvine-based Edwards Lifesciences Corp. that has an early lead with a U.S. trial under way.
Catheter valves are seen as the biggest advancement in heart valves in years. They potentially could open up the market for millions of patients who aren’t candidates for replacement valves implanted during open heart surgery.
The trial’s set to study the use of CoreValve in patients who are considered high risk for major surgery. Participants are set to get a catheter implant or a traditional valve via open heart surgery to measure survivability rates in both groups.
CoreValve “could move the needle positively” for Medtronic, said Sean Lavin, an analyst with Lazard Capital Markets in New York, in a research report.
“With a potential multibillion dollar U.S. market, a U.S. approval of CoreValve could favorably impact (Medtronic’s) anemic organic growth rate,” Lavin said.
Medtronic and Edwards now sell their catheter valves in Europe, where sales are small but fast-growing.
Catheter valve sales in Europe are expected to be about $400 million this year with analysts forecasting them to become a multibillion dollar market annually.
FDA approval of Edwards’ valve is expected next year.
Another Medtronic catheter valve, the Melody, has U.S. approval for use in a small amount of humanitarian cases.
Medtronic made its major entry into the catheter valve market in 2009, when it spent $700 million for Irvine-based CoreValve Inc.
ICU’s Gains
San Clemente-based medical device maker ICU Medical Inc. has sought to diversify in recent years, but its longtime relationship with its dominant customer continues to pay off.
ICU, which makes needleless connectors and other devices used to deliver intravenous fluids and cancer drugs, reported a profit of $9 million for the third quarter, up 42% from a year earlier and topping the $6.6 million expected on average by analysts.
Sales surged 40% to $75.7 million, surpassing the $66.6 million expected by Wall Street.
ICU saw “strong order patterns” from longtime major customer Hospira Inc., a drug and device maker based in Lake Forest, Ill., said Matt Dolan, an analyst with Newport Beach’s Roth Capital Partners LLC, in a research note.
Dolan said Hospira is attempting to gain infusion pump market share from the Chicago area’s Baxter International Inc., which is facing the effects of a recall.
Hospira has been a key customer for ICU for more than 15 years stretching back to Hospira’s days as part of Abbott Laboratories, another Chicago-area drug and device maker.
ICU got 53% of its $231.5 million in 2009 sales from Hospira.
In recent years, ICU has moved into making more custom intravenous sets and expanded into cancer drug delivery devices as part of a diversification strategy.
St. Joseph-Orange’s New Chief
Steve Moreau is the new chief executive of St. Joseph Hospital-Orange. Moreau succeeds Larry Ainsworth, who retired in June. Moreau takes over the hospital on Dec. 1.
He comes to St. Joseph from San Antonio Community Hospital in Upland, where he spent the past five years as chief executive.
Moreau has deep Orange County hospital roots: Before going to San Antonio, he was senior vice president and chief operating officer at Hoag Memorial Hospital Presbyterian in Newport Beach for 14 years.
While at Hoag, Moreau oversaw the development of what the hospital called centers of excellence in cancer, heart and vascular medicine, orthopedics and women’s services.
The married father of three grown children received his bachelor’s from San Diego State University and master’s degrees from California State University, Dominguez Hills and the University of Redlands.
Joe Randolph, executive vice president and chief operating officer of Orange-based parent St. Joseph Health System, had been serving as St. Joseph’s interim chief since July.
Moreau’s predecessor Ainsworth ran St. Joseph for 16 years.
Ainsworth’s accomplishments include opening a $203 million patient care tower in 2007 and adding a free-standing Center for Cancer Prevention and Treatment.
The hospital ranked No. 3 on the Business Journal’s most recent list of largest OC hospitals by revenue.
