The next frontier in the interventional cardiology world is transcatheter mitral valve repair and replacement. Fountain Valley-based Heartstitch Inc. said it received European CE Mark approval for its CoAp Pro for the former.
The device treats mitral regurgitation via use of “suture to remodel the mitral heart valves rather than the need to place a prosthetic device.” said Dr. Achille Gaspardone, a cardiologist at Sant’Eugenio Hospital in Rome, Italy.
The mitral valve and its regurgitant tendencies make the condition the most common type of moderate or severe heart valve disease among U.S. adults older than 55, according to the American College of Cardiology.
The company named Dru Dobbs president this month. He’ll continue to oversee manufacturing of its current product line, which includes the CoAp Pro, NobleStitch El Suture-based Closure System and Remo Pro.
Former President Richard Bjorkman stepped down from the role in order to spend more time with his family. He continues to serve as chief financial officer as a contractor, as well as the roles of director and corporate general counsel.
Eyeing FDA
Irvine-based Ivantis Inc. announced positive results of an international multicenter study comparing the effectiveness of the company’s Hydrus Microstent to another minimally invasive glaucoma surgery microstent, San Clemente-based Glaukos Corp.’s iStent Trabecular Micro-bypass.
The trial was designed to compare the safety and effectiveness of both devices in lowering intraocular eye pressure and reducing eye-drop medication use.
The 12-month, level one clinical study showed 47% of eyes in the Hydrus Microstent group were medication-free, compared to 24% of eyes in the iStent group.
Of the former group, 73% of patients achieved at least a 20% reduction in intraocular eye pressure while on fewer medications, compared to 47% in the latter.
Ivantis sponsored the study.
The Hydrus is designed to lower eye pressure in open-angle glaucoma patients by re-establishing flow through Schlemm’s canal, the eye’s natural fluid outflow pathway.
The device hasn’t been approved for sale in the U.S.; Ivantis submitted the product for Food and Drug Administration approval in October. Chief Executive Dave Van Meter said the study results are unrelated to the FDA submission.
Separately, Glaukos filed a patent-infringement lawsuit against Ivantis this month, alleging Ivantis’ Hydrus device infringes its patents related to certain core glaucoma technologies. Glaukos pioneered minimally invasive glaucoma surgery, launching the iStent, its first related device in 2012 in the U.S.
Ivantis declined comment on the lawsuit.
People Move
Greater Newport Physicians, among the county’s largest medical groups for independent physicians, named Dr. Mark Schafer chief executive, replacing longtime Chief Executive Diane Laird, who announced her retirement in March.
Laird and local doctors founded the organization in 1985. The medical group has nearly 1,000 doctors in Orange County and Long Beach, and joined the MemorialCare Medical Foundation in 2012.
Schafer will continue in his role of chief executive of the foundation, overseeing divisions of Greater Newport Physicians and the medical foundation’s Independent Practice Association, which complements MemorialCare Medical Group’s independent physician division. The foundation has over 2,000 physicians serving 700,000 patients throughout OC, Long Beach, the South Bay and Southern Los Angeles County.
The foundation is part of the MemorialCare Health System, which is based in Fountain Valley.
Bits & Pieces
Private equity firms are finding attractive investment opportunities in retail healthcare, or nonhospital care sites like dental clinics and urgent care centers, in the face of a growing emphasis on consumers, according to a 2018 report by consultant firm Bain & Co. The shift of care from traditional hospital settings was a reason St. Louis-based Ascension Health and Renton, Wash.-based Providence St. Joseph Health shelved their merger talks, which would have created the largest U.S. hospital system. Providence’s 14-hosptial Southern California network is based in Irvine and includes seven OC hospitals. … Rancho Santa Margarita-based device maker Applied Medical announced a study published in Surgical Endoscopy that said the use of a wound protector significantly reduces occurrence of infection among patients who’ve had gastrointestinal surgery. The risk is further reduced using dual-ring wound protectors compared to single-ring wound protectors. Applied makes Alexis, a dual-ring wound protector/retractor.
