Irvine heart valve maker Edwards Lifesciences Corp. has released more study results for its Sapien less-invasive valve.
Last month, the device maker presented survival data for patients implanted with the valve at a scientific conference in San Francisco.
The results looked at 339 patients who received Sapien valves in a Canadian study.
Based on a curve, 65% of patients who had Sapien inserted via a catheter through their leg artery survived at least 24 months after the procedure, according to Edwards.
Sixty-four percent of those who received the valve through an incision in the ribs lived for at least 24 months.
The results are based on what’s known as the Kaplan-Meier curve, or estimator, a statistical measurement that approximates survival rates. When a large enough sample of patients is used, the estimator can approach the true survival rate, but it shouldn’t be read as a literal figure of 64% of patients surviving two years after implantation.
Sapien and other catheter-inserted valves eliminate the need for open-heart surgery and are seen as broadening the market to patients considered too old or too sick for major surgery.
Edwards is conducting a large trial for Sapien with an eye toward Food and Drug Administration clearance in late 2011.
Sapien’s approved in Europe, where Edwards has said it expects sales to top $100 million this year.
The company has projected 2009 sales of $1.3 billion.
Analyst Kristen Stewart of Credit Suisse told the Wall Street Transcript, an industry newsletter, that she likes Edwards because of Sapien.
“It’s really one of the largest areas of new innovation,” she said. “I think transcatheter heart valves can certainly be the next big thing in medical devices.”
Catheter valves could be a “multibillion-dollar market opportunity” for a company of Edwards’ size, according to Stewart.
An analyst with UBS AG recently said that Edwards’ Sapien XT model has an advantage over rival Medtronic Inc.’s CoreValve, which is produced in Irvine in that patients who get a Sapien valve are less likely to need a new pacemaker.
CalOptima: Mission, Not Frills
CalOptima, an Orange nonprofit that administers Medi-Cal benefits for the county, is big on its mission—making sure needy children, families and people with disabilities have access to the healthcare they need.
“We take care of some of the most vulnerable residents of Orange County,” said Greg Buchert, CalOptima’s chief operating officer.
The group’s mission, Buchert said, provides “a little bit of a self-selection process” when it comes to CalOptima’s 390 workers.
“There are a lot of people who want to work for a nonprofit organization,” said Buchert, a doctor who has been with CalOptima since early 1995, just before it officially started.
Passion among employees earned CalOptima a spot on the Business Journal’s inaugural Best Places to Work list in the Sept. 28 issue. It ranked No. 3 in the large company category.
The list was compiled by surveying management on benefits and employees about their attitudes about work.
The passion of CalOptima’s employees drove its ranking on the list. Unlike others on our list, CalOptima it isn’t big on frills—it doesn’t offer an onsite gym, trainers or catered lunches, as we incorrectly reported last week.
CalOptima “is responsible for using taxpayer money to provide benefits in the most cost-effective way,” said Jennifer Santoro, a CalOptima pharmacist. “We are a health insurance plan. But we’re the government plan in this county and it’s actually their money that’s getting put to work.”
Besides the mission, Santoro said she likes CalOptima’s openness.
The nonprofit has “nothing hidden,” she said.
Workers have full access to information, she said. If something’s not disclosed, the reasons are explained in writing.
“It makes it a lot easier to do my job because I have full power to explain to a member or a doctor or a pharmacist why we’re making the decisions that we are,” Santoro said.
Allergan Partner
Irvine-based Allergan Inc. signed a deal with North Carolina-based Quintiles Transnational Corp. to help promote Allergan’s Sanctura XR medication for overactive bladder.
Quintiles’ salespeople are set to offer Sanctura to primary care doctors until late 2011, the companies said in a release.
Allergan will continue selling the drug to urologists using its own salespeople.
The company plans to pay royalties on sales by Quintiles until 2013.
Sanctura is a small part of Allergan. Second-quarter sales of the drug totaled $16 million, 45% higher than the $11.1 million of a year earlier.
Allergan has quarterly sales of about $1.1 billion.
The company acquired Sanctura in 2007, when it bought New Jersey-based Esprit Pharma for $370 million. Sanctura competes with Pfizer Inc.’s Detrol.
