Irvine-based Edwards Lifesciences Corp. and its chief executive, OC 50er Michael Mussallem (see Special Report pullout), are talking adoption of the company’s fast-growing less-invasive heart valve segment.
Transcatheter valves accounted for $268.5 million in sales during Edwards’ first quarter, a 42% jump from a year earlier.
“…We continue to see strong therapy adoption” with transcatheter heart valves, Mussallem said late last month on a conference call with analysts and investors.
He then gave listeners a review of transcatheter heart valve growth by region, starting with Europe, where Edwards estimates overall therapy adoption grew about 30%.
“Although transcatheter valves have been commercial for eight years, we believe demand remains strong for several reasons,” he said.
“First, general practitioners and general cardiologists are referring more patients to [transcatheter aortic valve replacement]. We believe this is being driven by growing awareness, favorable clinical outcomes and stable reimbursement.”
He also said advanced technologies, such as the Edwards Sapien 3 replacement heart valve, introduced last year, “are improving outcomes and stimulating procedural growth.”
He later added that sales of Sapien 3 represented more than 90% of the company’s transcatheter heart valve sales in Europe.
Mussallem said transcatheter aortic valve replacement is gaining favor in Europe because high-risk patients there are being treated on both physician judgment and their EuroScores. EuroScore is a method of calculating predicted operative mortality of patients undergoing cardiac surgery.
He moved on to Japan, where he said sales grew “sequentially.”
“We recently received regulatory approval for our 20-millimeter and 29-millimeter valve sizes, and reimbursement is expected to take effect in the near future. This will help broaden the population of patients who could benefit from this technology.”
Mussallem ended his tour with thoughts on the U.S., which had total sales of $131 million in the quarter, including observations on overall therapy adoption of transcatheter aortic valve replacement.
“First, awareness and adoption are still growing rapidly since the [U.S.] introduction of this therapy in late 2011. This confirms the large previously untreated patient population with severe aortic stenosis.”
Edwards is “pleased with the strength of our global [transcatheter valve] sales performance,” he said, adding that although he expects increased competition, underlying growth should remain high.
Endologix Adds Director
Irvine-based Endologix Inc. said late last month that it appointed Leslie Norwalk to its board of directors. Her appointment took effect May 1.
Endologix makes devices to treat abdominal aortic aneurysms.
Norwalk serves as strategic advisor and strategic counsel to national law firm Epstein, Becker & Green PC. Her positions also include serving as an adviser to New York-based private equity firm Warburg Pincus LLC.
She was previously acting administrator for the Centers for Medicare & Medicaid Services under the second Bush administration.
Norwalk “brings valuable regulatory and health policy experience that will help ensure Endologix is well-positioned in the evolving marketplace,” Endologix Chief Executive John McDermott said in a news release.
OvaGene Hire
Irvine-based OvaGene Oncology Inc. recently named Dr. Patricia Judson its chief medical officer, replacing Dr. Neil Finkler.
OvaGene specializes in the development and commercialization of personalized, gene-based diagnostics for gynecologic cancers and premalignant disorders.
Judson, a board-certified obstetrician-gynecologist and gynecologic oncologist, was most recently with the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla.
Bits & Pieces
Tustin-based Toshiba America Medical Systems received a “medical imaging company of the year” award from San Antonio, Texas-based marketing research company Frost & Sullivan, which said it honored the unit of Japan-based Toshiba Corp. for its focus on customer partnerships. … Aliso Viejo-based UST Global Inc. is working with Orlando, Fla.-based Kony Inc. and Blue Cross of Idaho on a mobile application that allows its users to find urgent-care facilities in their areas, identify in-network doctors, and access healthcare information.
