Transcatheter heart valves, including those by Irvine-based Edwards Lifesciences Corp., took center stage at a large interventional-cardiology meeting this month in Washington, D.C.
Analyst Danielle Antalffy and colleagues at Boston-based Leerink Swann LLC noted in a research report that transcatheter aortic valve replacement “again dominates an otherwise relatively quiet” Transcatheter Cardiovascular Therapeutics meeting.
“While this year’s meeting isn’t likely to match the drama of last year’s during which we saw 1-year results from [Medtronic Inc.’s] U.S. CoreValve pivotal trial in extreme risk patients, there are a plethora of relevant sessions highlighting key questions and controversies around interventional cardiology devices and procedures,” Antalffy wrote.
Leerink cited several presentations to watch:
• Five-year PARTNER I clinical trial data for Edwards’ Sapien valve.
Edwards said Sept. 13 that the trial data showed “significant patient benefits” for those who received a Sapien implant. The trial covered the outcomes of 358 people who had inoperable aortic stenosis and received treatment between 2007 and 2009.
“These longer-term results from PARTNER’s inoperable cohort indicated that [transcatheter aortic valve replacement] was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalizations,” Dr. Michael Mack, the cardiovascular service line chair for Dallas-based Baylor Scott & White Health, said in a news release.
The trial has “historical significance” in the development of transcatheter aortic heart valve replacement “and continues to provide the clinical community with important information about the durability and performance of the Edwards Sapien valves,” Mack said.
• U.S. cost-effectiveness data for Minneapolis-based Medtronic’s CoreValve, which was developed in Orange County. Medtronic also presented pivotal trial data in extreme-risk patient populations during TCT.
Medtronic said its cost-effectiveness study data showed that CoreValve patients used fewer healthcare resources related to procedure time, ICU time, hospital length of stay, and the need for rehabilitation services at discharge.
“In an age where healthcare costs are under increased scrutiny, it is especially important and reassuring to know that this new self-expanding valve also is cost-effective for the U.S. healthcare system,” said Dr. Matthew Reynolds of Lahey Hospital and Medical Center in Burlington, Mass. Reynolds presented the cost-effectiveness data.
Medtronic also presented two-year results from 305 “extreme-risk” patients who received CoreValve. That data showed that death and major strokes two years after implant were low for that group of patients.
Leerink weighed in on which data is more likely to move a stock.
“Of these, we’d expect [Medtronic’s] CoreValve to be the most impactful from a stock perspective, with the cost-effectiveness data potentially providing some insight into the impact and relevance of a significantly higher pacer rate,” Antalffy said.
She was referring to the need for some patients to have permanent pacemakers implanted as a complication of transcatheter heart valve replacement.
Leerink added that it expected mitral valve replacement and repair to “be a much-discussed topic, though we expect no updates on implants to-date” for Fortis, a valve that Edwards is developing.
Sabra’s Credit Line Hiked
Irvine-based Sabra Health Care REIT Inc. said this month that its borrowing capacity on its secured revolving credit line has been increased from $375 million to $650 million. The owner of healthcare real estate also announced that its unsecured revolving credit line was amended and restated, although it did not say how much it can borrow.
“The unsecured nature of the [revolving credit line] is a nice step forward for Sabra giving us greater financial flexibility and continuing our progression toward reaching investment-grade,” Rick Matros, Sabra’s chief executive, said in a statement.
An increased credit line “enhances our opportunity to look at larger investments in addition to continuing with our bread and butter deals,” Matros said.
Sabra’s lenders include Barclays Bank PLC, Wells Fargo Bank NA and SunTrust Bank, among others.
Bits & Pieces
Newport Beach-based Alliance HealthCare Services Inc. said its Alliance Oncology division is establishing a radiation therapy department at the Charleston Area Medical Center’s Cancer Center in Charleston, W.Va. The center sees more than 20,000 patients yearly, according to Alliance. … NanoSomiX Inc., an Aliso Viejo-based startup, said it would start providing a blood test to researchers and drugmakers studying treatments for Alzheimer’s disease that it says can, up to 10 years prior to diagnosis, reliably predict whether a person would develop the disease.
