Less-invasive replacement heart valves from Irvine-based Edwards Lifesciences Corp. and rival Medtronic Inc. got a thumbs-up late last month from an analyst.
Rick Wise of Leerink Swann LLC said in a research note that he left several meetings with heart doctors “increasingly encouraged” about the long-term growth potential of the valves.
Valves such as Edwards’ Sapien and Medtronic’s CoreValve are implanted into patients via catheters through an artery in the leg or a small rib incision, instead of during open heart surgery.
The devices, known as transcatheter valves, are considered one of the largest developments in the field in years and are seen as creating options to treat patients who can’t handle traditional surgery for valve replacement.
“Each of the three interventional cardiologists we met with was tremendously excited about transcatheter heart valve technology,” Wise said. “In their minds, transcatheter valves will be the next significant cardiology growth market.”
Edwards, which got into transcatheter valves through its purchase of Percutaneous Valve Technologies Inc. in late 2003, is considered to have a head start on Medtronic.
Medtronic, which bought Irvine-based startup CoreValve Inc. in 2009, isn’t expected to commercialize its valve in the U.S. until the middle of the decade.
Both valves are sold in Europe.
A U.S. trial for Edwards’ Sapien “will be critical to watch in gauging prospects for approval and uptake.”
Edwards is hoping for Food and Drug Administration approval in late 2011.
“It is hard to peg the market opportunity precisely,” Wise said. “But if launched successfully, it seems clear this could be the next significant billion-dollar-plus opportunity in interventional cardiology.”
Besides Edwards and Medtronic, Wise said other companies that could enter the market are Abbott Laboratories, which bought valve maker Evalve Inc. of Menlo Park last year, and St. Jude Medical Inc.
European doctors have taken to Sapien and CoreValve, Wise said.
“Medtronic’s CoreValve is clearly experiencing supply constraints and is unable to meet all European demand, according to one European physician consultant,” Wise said.
American consultants, Wise wrote, told him they believe that pressure’s increasing on doctors, the FDA and device makers “to safely, successfully and rapidly commercialize the technology.”
Medical Office Buy
A healthcare real estate investment fund of Santa Ana-based Grubb & Ellis Co. said it bought a medical office building in a New Orleans suburb. A Securities and Exchange Commission filing listed the price at $7 million.
The Lacombe Medical Office building has 34,000 square feet of space and is fully leased to five tenants, all of which specialize in heart surgery.
The building is on the campus of the Louisiana Medical Center and Heart Hospital, a facility that just completed a $40 million, 109,000-square-foot, 120-bed patient tower in 2009.
Grubb & Ellis said its second healthcare fund is seeking to raise up to $3 billion to buy more properties, particularly medical office buildings and other healthcare facilities.
Feds Warn Device Maker
Cardiac Science Corp., a Seattle-area medical device maker that got its start in Irvine, saw its shares drop more than 20% last month after it said in an SEC filing that it received a warning letter from the FDA.
Regulators said that Cardiac Science, which moved from OC to Bothell, Wash., in 2005, wasn’t adequately dealing with problems related to 300,000 of its automated external defibrillators that may not work during resuscitation attempts.
Cardiac Science said in November that some of its defibrillators, which deliver electric shocks to people who are suffering heart attacks, were faulty and it issued a “voluntary medical device correction” for the devices.
But the FDA said that that fix wasn’t designed to prevent a component in the defibrillator’s failure.
The device maker said that if it didn’t adequately address the problems that it could be subjected to actions such as seizure, injunction and civil monetary penalties.
Correction
A story of mine last week on hospital purchasing groups misspelled the name of an executive vice president of Dallas-based Broadlane, a buying group. His name should have been spelled Joe Greskoviak.
Bits and Pieces:
Terry Belmont, chief executive of UCI Medical Center, an Orange teaching hospital, is serving as chair for the Orange County March of Dimes’ March for Babies fundraiser, which takes place at the end of April … The Richard A. Neubauer Research Institute in Newport Beach is going to sponsor the seventh annual International Symposium for Hyperbaric Oxygen at the Irvine Marriott in July.
