Edwards Lifesciences Corp. (NYSE: EW) has kicked off a pivotal domestic trial of the Centera transcatheter heart valve.
The device is designed to treat severe symptomatic aortic stenosis patients, who typically need aortic valve replacement and are at immediate risk of open-heart surgery.
The Irvine-based company describes Centera as “self-expanding” within an artery, and says the valve is “repositionable and retrievable.”
The one-year, multicenter study seeks to enroll approximately 1,000 patients.
Centera comes with enhanced design features, “including a motorized handle that enables stable valve deployment, [allowing] for a simple procedure with compelling outcomes,” said Dr. Didier Tchéché of Clinique Pasteur in France, in a statement this year.
Centera received European CE Mark approval, the European equivalent of Food and Drug Administration approval, in February.
The U.S. study plans come in the middle of a few roller-coaster weeks for the stock of Orange County’s largest publicly traded company, which is valued at about $30 billion.
The medical device giant’s stock surged late last month on news of it being a potential takeover target of New Brunswick, N.J.-based Johnson & Johnson (NYSE: JNJ). Shares reached a 52-week high of $174, putting its value near $36 billion. They’ve since dropped amid overall stock market weakness.
Edwards’ long-term outlook remains very strong, according to analysts.
The company, unlike competitors in the cardiovascular sector that have continued to diversify in recent years, has honed its focus on core competencies in structural heart and critical care, according to an analyst report by Guggenheim.
Edwards, which already has more than half of the aortic transcatheter heart valve market, has a research and development pipeline focused heavily on the mitral and tricuspid opportunities that will drive its next growth leg.
It has an active pivotal clinical trial of its Cardioband technology for patients with mitral regurgitation, when a mitral heart valve doesn’t close tightly, resulting in blood flowing back into the heart causing shortness of breath and fatigue.
Edwards acquired Cardioband in January 2017 through its buy of Israeli device maker Valtech Cardio Ltd. for $690 million.
Competitor Abbott Laboratories (NYSE: ABT) has its own mitral valve product, which recieved FDA approval for a next-generation version in July. It said last month that its MitraClip device significantly reduces rehospitalizations in patients with mitral heart failure and severe mitral regurgitation.
The results were disclosed at the annual Transcatheter Cardiovascular Therapeutics convention in San Diego.
The study “provided rigorous proof that mitral repair [and perhaps replacement] can alter the clinical course of patients with moderate-severe or severe mitral regurgitation,” according to a SunTrust Robinson Humphrey analyst report.
FDA OKs
• Starr Surgical Co. (Nasdaq: STAA) received FDA approval of Visian Toric ICL, a device used for correction of nearsightedness and astigmatism.
The company plans to roll out the implantable device in the U.S. next month. It’s designed for use in patients ages 21 to 45.
The Monrovia-based lens manufacturer has a research and development facility in Tustin and a raw-material manufacturing facility in Aliso Viejo.
Its market cap is $1.8 billion.
• Los Alamitos-based Venture Heat recently got FDA clearance of its pain relief Infrared Heat Therapy Wrap.
The product uses infrared rays to provide low-energy heat therapy for relief from deep-tissue and stiff-muscle pain and for faster healing. It’s used to treat conditions such as back and neck pain, sports injuries, and arthritis. The product’s 3D tailoring gives it a better fit and ensures heat is delivered directly to areas of pain, according to the company.
President Eddie Chen said that while electric heating pads, microwaveable packs, chemically activated patches, and other heat-therapy applications are available, the company’s pain-relief product line provides “a deep, penetrating, soothing and therapeutic heat that starts as infrared light, quickly turning to heat once it hits the source and origin of your discomfort.”
He said the product delivers deep heat that “penetrates up to three inches, even into the bone matter.”
