Edwards Lifesciences Corp. of Irvine and Minnesota-based Medtronic Inc., which has about 700 local employees, are sharing study data for their less-invasive heart valves to customers through the scientific show circuit.
Both Edwards and Medtronic made presentations of their respective technologies at the recent American College of Cardiology’s annual meeting in Chicago.
Data from Edwards’ Partner trial for the Edwards Sapien less-invasive replacement valve showed elderly patients who received it had similar death rates and risk of stroke at two years as those given a new valve through open-heart surgery. The study showed that 33.9% of Sapien patients died compared to 35% who went through open-heart surgery—a difference that is not statistically significant.
“We think the concern over strokes has diminished with the study showing the risk declined after 30 days of implantation,” Phillip Seligman, a Standard & Poor’s Capital analyst, told Reuters.
Partner looked at 699 patients who were at high risk for open-heart surgery and whose average age was 84.
The Food and Drug Administration approved Sapien—which costs about $30,000—in November for patients deemed too sick for open-heart surgery to treat aortic stenosis, a narrowing of the valve that controls blood flow to the heart. Edwards is looking for wider usage of Sapien and expects a FDA panel to review the data in the next few months.
Meanwhile, Medtronic presented data showing that its CoreValve replacement heart valve eased heart-failure symptoms in a study of 1,015 patients who had severe aortic stenosis. That study showed that after six months, 82.7% of the patients who received implants were alive with few complications.
Medtronic is expected to conclude its clinical studies next year, and it has forecast FDA approval for CoreValve in 2014.
Medtronic got CoreValve in 2009 after spending $700 million to purchase Irvine-based CoreValve Inc.
Both Sapien and CoreValve are sold in Europe.
Sapien and CoreValve were dubbed “products to keep your eyes on” by the Motley Fool investor website.
Quality Rating
Irvine healthcare software maker Quality Systems Inc. was downgraded by Zacks Investment Research at the end of March.
The Chicago-based research service lowered its recommendation to “neutral,” even though it said in a report that Quality has benefited from the migration of various healthcare practices to electronic health records after the passage of federal economic stimulation legislation in 2009.
Zacks also mentioned Quality’s 2011 buy of Virginia Beach, Va.-based IntraNexus Inc., which the agency said “is expected to facilitate its progress in the small hospital market.” Overall, Quality’s “in a strong position to undertake merger and acquisition activity.”
But Zacks also raised potential concerns about Quality, which has seen its stock rise up the Wall Street charts for more than a decade.
“The business is crowded with many players operating in the upper end of the market where Quality Systems has traditionally been strong,” Zacks said. “We harbor doubts about the company’s ability to penetrate the low end of the (electronic health record) market where it faces competition from lower-price, cloud-based (electronic health record) models.”
Zacks said it also was concerned about execution risks emanating from Quality’s entry into the rural inpatient hospital market.
Nihon Kohden
Nihon Kohden America Inc., a Foothill Ranch maker of patient monitors, secured a physiological monitoring group purchasing contract from Brentwood, Tenn.-based HealthTrust Purchasing Group LP.
Nihon Kohden earlier signed a physiological monitoring deal with Premier Healthcare Alliance, a Charlotte, N.C.-based purchasing group. Nihon Kohden America is a subsidiary of Japan-based Nihon Kohden Corp.
Bits and Pieces
Drug maker Spectrum Pharmaceuticals Inc., which moved its headquarters from Irvine to Henderson, Nev., last year, is buying Allos Therapeutics Inc., a cancer drug maker in Westminster, Colo., for $206 million in cash plus possible milestone payments. Spectrum announced the buy shortly after disclosing that its apaziquone bladder cancer drug candidate failed to achieve a statistically significant reduction in the rate of tumor recurrences compared with a placebo. Spectrum is working with Allergan Inc. of Irvine to develop apaziquone for North America and Europe. … The CalOptima Regional Extension Center in Orange said it achieved its goal of enrolling 1,000 primary care providers in its program. The center offers services that help doctors transition from paper to electronic medical records. … Auxilio Inc., a Mission Viejo company that helps hospitals and healthcare providers cut their dependence on paper records, was recently recognized in a report issued by Quocirca, a U.K.-based research and analysis company that looks at the business impact of information technology and communications.
