Several Orange County companies that specialize in cardiovascular devices, including Irvine-based Edwards Lifesciences Corp., were showcased at last month’s Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C. The event focuses on heart catheters and stents.
Edwards gave an update on a clinical trial for its LifeStent product, which it said showed “statistically superior results.” LifeStent is used to treat diseased arteries in the upper leg and knee.
Edwards said the trial compared the use of LifeStent to traditional balloon angioplasty when treating diseased blood vessels around the heart.
Edwards is talking with the Food and Drug Administration for pre-market approval of LifeStent to be used in the femoral artery.
But Edwards’ shares fell 3% that day. A day earlier Edwards said the U.S. launch of its Magna heart valve would be delayed. The company had expected to launch the valve in the fourth quarter, but said it was responding to questions from the FDA and was no longer confident of that timeline. Edwards counted a recent market value of about $2.7 billion.
Besides Edwards, other local device makers participated in the symposium.
They included CoreValve Corp., an Irvine medical device maker, which used its ReValving system to implant a prosthetic heart valve in a 74-year-old woman who was considered too high risk for conventional open-heart surgery.
After the event, Alexander Arrow, an analyst with Lazard Capital Markets, said in a report that he believed doctors’ interest in heart valves that can be inserted without invasive surgery is now surpassing interest in drug-coated stent therapy.
“(Drug-coated stent) scientific sessions played to audiences of 100 to 200 in a room with approximately 1,500 seats, while aortic percutaneous valve sessions played to half-standing audiences of 800 to 1,000 in a room with approximately 600 seats,” Arrow said.
Both CoreValve and Edwards’ respective valves will have a market, Arrow said. Arrow noted that doctors will use CoreValve for patients with “difficult, tortuous or just plain small leg arteries. Edwards’ Sapien will be used in cases where the patient’s leg arteries permit a larger catheter.”
And TherOx Inc., which is also based in Irvine, shared trial results of its SuperOxygenation Therapy, which involves the creation and delivery of superoxygenated arterial blood to salvage heart muscle in acute heart attack patients. TherOx said it successfully met endpoints for the trial, and that the data is going to be submitted shortly to the FDA as part of its pre-market approval application.
Warbug, Bausch Deal Official
Bausch & Lomb Inc., the eye care company that was once pursued by Santa Ana-based Advanced Medical Optics Inc., now is officially off the public market.
Warburg Pincus, the New York private equity firm, said at the end of the month it wrapped up its buy of Bausch for $4.5 billion, including some $830 million in debt.
Advanced Medical first offered $4.23 billion for rival Bausch at the end of May,right around the time that the company voluntarily recalled its Complete MoisturePlus contact lens care solution when regulators linked it to a rare eye infection that could cause blindness.
Advanced Medical has since re-launched Complete with a new formula.
Advanced Medical sought Rochester, N.Y.-based Bausch for several reasons, including the fact that Bausch had a pair of product lines that Advanced Medical wasn’t in,contact lenses and eye drugs.
Bausch had already accepted the go-private Warburg bid when Advanced Medical made its interest known.
Advanced Medical walked away from Bausch in the beginning of August, after several weeks of back-and-forth.
Advanced Medical had faced strong shareholder opposition for its Bausch bid, particularly from activist San Francisco hedge fund ValueAct Capital LP, which once held 15% of the eye care and device maker. Since then, ValueAct has reduced its stake in Advanced Medical.
Bits and Pieces:
J.D. Kleinke, a medical economist, author and former healthcare information technology entrepreneur, is discussing “The Once and Future Healthcare Information Revolution” on Tuesday at a Costa Mesa healthcare information technology summit sponsored by UnitedHealthcare of California, which has an office in Cypress. Representatives from the state Department of Managed Health Care, Centers for Medicare and Medicaid Services, the California Association of Health Plans and the California Association of Physician Groups are scheduled to appear Marcus & Millichap Real Estate Investment Services’ Newport Beach office said it sold the 35,185-square-foot Anaheim Medical Building in Anaheim for $2.2 million to TTTC LLC. Pasha Darvishian, a senior associate in the office, represented the buyer and the seller, ACRI-Harbor LLC UC Irvine Family Health Center-Anaheim opened a new facility for women and expectant mothers on West Carl Karcher Way in Anaheim.
