Medtronic Inc. is proceeding with key trials of a less-invasive replacement heart valve it developed here.
The Minnesota-based diversified medical device maker employs about 700 people in Irvine, Lake Forest and Santa Ana. It’s building a large plant in Santa Ana and plans to consolidate its operations there.
Medtronic said in late August that it had finished enrolling in a study of high-risk patients in its CoreValve pivotal trial. There is a total trial enrollment of more than 1,500 patients who have severe aortic stenosis, or a narrowing of the body’s primary artery. Those patients are at high or extreme risk for aortic valve surgery.
The trial will be run by heart teams made up of interventional cardiologists and cardiac surgeons at 45 clinical institutions across the U.S. The trial actually will be comprised of two studies: high-risk patients and extreme-risk patients.
In the high-risk study, its primary endpoint is freedom from all-cause death at 12 months after implantation, while in the extreme-risk arm the primary endpoint is freedom from all-cause death or a major stroke within 12 months from implantation.
Medtronic also said that it received conditional approval from the Food and Drug Administration to start evaluating CoreValve in a separate trial known as the Surgical Replacement and Transcatheter Aortic Valve Implantation trial. That will look at less-sick patients who historically are treated with open-heart surgical aortic valve replacement.
Enrollment in that trial is expected to begin within weeks. It will evaluate some 2,500 patients.
Medtronic got CoreValve in 2009, when it spent $700 million to buy CoreValve Inc., which was based in Irvine. CoreValve competes with Irvine-based Edwards Lifesciences Corp. in Europe.
Market-watchers have anticipated that Medtronic will submit CoreValve for FDA approval in 2014-2015.
Auxilio Projection
Mission Viejo-based Auxilio Inc. issued guidance for 2012 revenue projecting a 50% jump from last year as the result of contracts closed since December.
The company had revenue of about $17.3 million through the first six months of 2012.
Auxilio helps hospitals and other healthcare providers reduce their dependence on paper records. It signed contracts representing 45 hospitals and worth an estimated $90 million between December and June.
Auxilio’s recently acquired clients include Sharp Health Care in San Diego and the Bon Secours Health System, a Maryland-based Catholic hospital operator run by former St. Joseph Health Chief Executive Richard Statuto.
Buildings Sold
Two medical office buildings in La Palma were part of a recent sale for undisclosed terms to Los Angeles-based Positive Investments Inc.
The Orange County buildings total 58,800 square feet and were purchased from La Palma Medical Buildings LLC. John Smelter of Marcus & Millichap’s San Diego office represented the seller.
La Palma Medical Buildings, located at 5451 and 5471 La Palma Ave., are situated adjacent to La Palma Intercommunity Hospital. Major tenants include Laboratory Corp. of America, LP Towers Pharmacy and La Palma Intercommunity.
Positive’s deal also includes the Bellwood General Hospital Medical Center, a 36,800-square-foot medical office building located in Bellflower.
Diagnostics Partners
NextGen Healthcare Information Systems LLC, a unit of Irvine medical software maker Quality Systems Inc., signed a deal with Fort Lauderdale, Fla.-based Nipro Diagnostics Inc.
The deal calls for Nipro to add its TRUEresult blood glucose monitoring into the NextGen Ambulatory electronic health record. It allows doctors to have instant access to data points captured by their diabetic patients who use TRUEresult.
Doctors will also be able to perform diagnostic tests and directly enter the information into the patient’s chart. NextGen said in a release that would eliminate the need to manually re-enter patient data, leading to streamlined processes, reduced data entry errors and more efficiencies.
Bits and Pieces
Oxygen Biotherapeutics Inc. is relocating its research and development from Costa Mesa to the Research Triangle Park area of North Carolina. Morrisville, N.C.-based Oxygen makes medical and cosmetic products designed to deliver oxygen to tissues in the body. The company said that it cut three jobs in Costa Mesa due to the relocation. … Toshiba America Medical Systems in Tustin named Satrajit Misra senior director for its CT business unit. Misra was formerly senior director and head of product marketing for nuclear medicine at Philips Healthcare, a unit of Netherlands-based Royal Philips Electronics … Irvine-based molecular diagnostics provider CombiMatrix Corp. named Mark McDonough chief commercial officer. McDonough formerly was vice president of sales, customer service and training at Pathwork Diagnostics in Redwood City.
