Irvine-based Edwards Lifesciences Corp. and a couple of its competitors had an eventful mid-March on the clinical trial and regulatory fronts for their less-invasive replacement heart valves.
Edwards’ shares rose 10% on March 16 on positive results from several heart valve studies presented at the American College of Cardiology’s meeting in San Diego.
The device maker said a trial of its Sapien 3 valve demonstrated low mortality and low rates of valve leaks and strokes 30 days after implanting it in high-risk patients. It also said final five-year clinical data for patients treated with the first-generation Sapien valve demonstrated equal outcomes to traditional open-heart valve replacement surgery, as well as durable valve performance.
Those trial results, which involved more than 1,600 patients, “demonstrate the most significant progress in the development of [transcatheter aortic valve replacement] and the Sapien family of valves since the first [Placement of Aortic Transcatheter Valves] study was initiated in 2007,” Dr. Susheel Kodali, director of the heart valve program at New York Presbyterian-Columbia University Medical Center, said in a news release.
Kodali is the co-principal investigator for the Sapien 3 studies.
Edwards is preparing to launch Sapien 3 in the U.S. early next year, pending Food and Drug Administration approval.
Less-invasive heart valves accounted for $943.6 million, or 41%, of its $2.3 billion in sales last year. The company is scheduled to release its financial results in late April.
“We believe this positive piece of news will [bring] higher demand for Edwards’ Sapien family of valves, thus facilitating the company to achieve its long-term goal in the transcatheter heart valve space,” Chicago-based Zacks Investment Research said in a blog post that addressed the study.
Edwards rival Medtronic PLC, which is based in Ireland and operates from Minnesota, also had some news from the meeting.
A Danish trial that used its CoreValve, a Sapien competitor developed in Orange County, showed that low-risk patients were no more likely to suffer stroke, heart attack, or death a year after receiving a transcatheter valve than those whose diseased heart valves were replaced through traditional open-heart surgery, Reuters reported.
Medtronic and Edwards weren’t the only companies with less-invasive valve news in recent weeks.
Minnesota-based St. Jude Medical Inc., which has just over 350 workers in Irvine, said European regulators recently restored the CE mark for its Portico less-invasive valve.
Sales of Portico went on hold last fall after St. Jude discovered there were concerning, unexplained motions in the valve’s leaflets.
St. Jude officials said at the conference that the company was working with the FDA to resume clinical studies for Portico, according to industry newsletter Med Device Online.
Device Maker Consolidates, Hires
MRI Interventions Inc., which makes minimally invasive devices for brain and heart surgeries, said it’s consolidating its major business functions from Memphis, Tenn., to its Irvine corporate office and will close the Tennessee location.
MRI makes the ClearPoint, which uses a hospital’s intraoperative or diagnostic MRI scanner to enable a range of minimally invasive brain procedures.
The company also announced that Harold Hurwitz is joining as its next chief financial officer.
It said he will start as vice president, finance, and assume the CFO position after the company files its 10-Q report with the Securities and Exchange Commission.
MRI said in an SEC filing that it wouldn’t retain its Memphis-based employees, including Hurwitz’ predecessor, David Carlson.
Bits & Pieces
Costa Mesa-based Nemus Bioscience Inc. said it was going to conduct clinical studies on the medical utility of cannabinoids as anti-infective therapeutics. It said studies would be performed at the University of Mississippi in Oxford, Miss. … Rancho Santa Margarita-based Integrated Endoscopy Inc. demonstrated its nuvis single-use arthroscopic surgical instrument at the American Academy of Orthopaedic Surgeons’ 2015 annual meeting last week in Las Vegas. Nuvis received 510(k) clearance from the FDA last July, and the company plans to make it available nationwide in the fourth quarter. … CSP LLC in San Clemente introduced LippEase, a cold sore remedy it says addresses the cause of the mouth malady.
