Edwards Lifesciences Corp. is getting approving nods in the wake of positive clinical trial results for its Edwards Sapien transcatheter heart valves on a sizable patient population.
Shares of the Irvine-based cardiovascular device company, OC’s largest by market value at some $22.1 billion as of early this month, shot up after it reported its Sapien valve family worked as well as or better than traditional open-heart surgery for intermediate-risk patients with aortic stenosis, or a narrowing of the aortic valve.
Edwards said a trial of Edwards Sapien in intermediate-risk patients showed a death rate of 19.3% versus 21.1% in open-heart surgery patients. The company also said a trial of its Sapien 3 valve showed it’s superior to open-heart surgery in intermediate-risk patients.
Results from that study could lead to Edwards’ valves “becoming more widely used, giving it a valuable edge in its battle for market share with med-tech Goliath Medtronic [PLC],” according to Todd Campbell, a Dover, N.H.-based investor writing for the Motley Fool website.
Campbell mentioned in an article on the valve battle that 30% to 40% of aortic stenosis patients are categorized as being at intermediate risk in open-heart surgery, compared to roughly 10% who are categorized as being at high risk.
Trial results could “significantly [expand] Edwards Lifesciences’ target market” until Medtronic comes out with its own intermediate-risk results, Campbell said. He noted that figures from Medtronic show that the transcatheter aortic valve replacement market will reach $4 billion by 2020.
Campbell, however, said Edwards and Medtronic, which is based in Ireland for tax purposes, operates out of Minnesota and has about 1,300 local workers, could get some benefit from a likely boost in the growth of transcatheter aortic valve replacement in newly diagnosed patients and from failing valves in patients who received traditional surgical replacement valves.
Ensign Grows in Texas
Mission Viejo-based nursing home operator Ensign Group Inc. has bought 18 skilled nursing facilities in Texas on undisclosed financial terms. The acquisition is expected to take effect May 1.
The properties are currently owned or leased by affiliates of San Antonio-based Legend Healthcare LLC. Ensign said in a news release that the facilities will be operated by Texas-based Ensign subsidiaries.
It will lease 15 of the operations when the deal closes under a long-term master lease with Murfreesboro, Tenn.-based National Health Investors Inc. It will acquire the real estate in two of the operations and add the 18th operation to the master lease with National Health after a short-term sublease with Legend.
Ensign’s new Texas portfolio includes facilities in Greenville, Euless, Gladewater, Paris, Austin, Houston, Ennis, Marble Falls, Katy, Kyle, New Braunfels, San Antonio and McAllen.
The deal brings its portfolio to 204 healthcare facilities, 15 hospice agencies, 15 home health agencies, three home care businesses and 17 urgent care clinics in California and 13 other states.
Bits & Pieces
Hoag Memorial Hospital Presbyterian, with campuses in Newport Beach and Irvine, said it received a “Blue Distinction Center+” designation by insurer Anthem Blue Cross’ Blue Distinction Centers for Cardiac Care program. The centers are nationally designated healthcare facilities shown to deliver improved patient safety and better health outcomes based on objective measures. … Aliso Viejo-based Global Genes, a nonprofit advocacy organization, released a toolkit designed for use by patients with rare diseases. Global said in a news release that the toolkit will provide resources for rare disease patients and their advocates to help them better understand and engage in clinical research and drug development. … Costa Mesa-based StudyKIK said it’s working on creating clinical trial industry standard reviews and approvals of digital clinical trial advertisements put out by institutional review boards. The boards review and approve all scientific research on human subjects.
