Irvine-based Edwards Lifesciences Corp.’s run of good news continued this month.
The device maker said it received European regulatory approval for its Edwards Intuity Elite heart valve.
Intuity Elite is used in surgical aortic valve replacement procedures. Edwards said it’s designed to facilitate smaller incisions in surgical procedures and was built “on extensive evidence supporting the durability of the Carpentier-Edwards Perimount heart valve design.”
“Our experience with the Edwards Intiuity [valve] has shown the ability to implant the valve through smaller incisions, with significantly reduced cross-clamp time and improved hemodynamics,” Dr. Michael Borger, associate director of the department of cardiac surgery at the Leipzig Heart Center in Germany, said in a news release.
The valve “can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits,” said Donald Bobo Jr., Edwards’ corporate vice president, heart valve therapy.
Clinical trial results that compared Edwards Intuity to a full sternotomy surgical approach with conventional heart valves were presented during the Society of Thoracic Surgeons’ annual meeting in January in Orlando, Fla.
The study, among other things, showed that patients who received Edwards Intuity valves demonstrated a 24% reduction in ischemic time, or the amount of time that blood flows to and from the heart is stopped during surgery, compared to surgeries inserting conventional bioprosthetic heart valves.
It also showed that blood flow and hemodynamics were superior to conventional bioprosthetic heart valves at a three-month follow-up.
Edwards said Intuity Elite will be commercially available at hospitals throughout Europe. It added that the valve is “supported by favorable reimbursement in Germany as part of diagnosis-related group mapping that includes the new category of rapid-deployment aortic valve systems.”
Intuity Elite isn’t yet available for sale or use in the United States.
Edwards said it’s now being studied as part of what it called the first domestic trial of a rapid deployment system for surgical aortic valve replacement.
Blood Bank HQ to Irvine
The University of Colorado’s ClinImmune Labs has picked Irvine for the corporate office and customer service functions of CariCord Inc., a public-private venture that offers umbilical cord blood stem cell banking.
CariCord said in a news release that cord blood stem cells are now used in Food and Drug Administration-approved treatments for more than 80 diseases.
“CariCord’s clients will have the confidence that they preserved their child’s life-saving cells for the possibility of future care under the same rigorous standards of the University of Colorado bank that has a long track record supplying successful transplant units worldwide,” said Calvin Cole, CariCord’s Irvine-based chief executive.
ClinImmune Labs, CariCord’s parent, has been processing cord blood units under federal contract since 2006. Laboratory processing will take place at ClinImmune’s facility at the University of Colorado School of Medicine in Aurora.
Direct Flow Grows in NorCal
Direct Flow Medical Inc., a heart valve startup that manufactures its devices in Lake Forest, said in published reports late last month that it would expand its Santa Rosa headquarters to support additional staff.
Direct Flow is planning to expand its overall workforce from about 160 to more than 300 worldwide. The majority of its staff is in Santa Rosa, with some 56 workers in Lake Forest, and plans to add 45 more by year-end.
The device maker said demand has been growing since European regulators approved what Direct Flow calls “the first fully repositionable 29mm transcatheter aortic heart valve.”
“Customer demand from physicians has been very strong since we were approved to market our device in Europe in early 2013. We are also progressing on our U.S. regulatory path, getting us one step closer to U.S. availability,” Michal Burgess, Direct Flow’s vice president of finance, told the North Bay Business Journal.
Direct Flow has long touted its valve as being different from entries such as Edwards’ Edwards Sapien and Minneapolis-based Medtronic Inc.’s Orange County-developed Medtronic CoreValve because of its ability to be repositioned, among other things.
Bits & Pieces
David Erickson, Edwards Lifesciences’ vice president of investor relations, is one of five people named to the 2014 fellow class of the Alexandria, Va.-based National Investor Relations Institute. The program recognizes members who have distinguished themselves on the basis of organizational leadership, “as well as their integrity, involvement and contributions to the IR profession throughout their careers,” according to the institute. … Tustin-based drug developer Peregrine Pharmaceuticals Inc. said three of its preclinical abstracts were presented at the annual meeting of the American Association for Cancer Research April 5 to 9 in San Diego. The abstracts included studies looking at Peregrine antibodies when administered in combination cancer treatment regimens, including radiation and approved and developmental cancer immunotherapies.
