Irvine-based medical device maker Inari Medical Inc. received Food and Drug Administration clearance for the FlowTriever System, which is used to treat pulmonary embolism, a condition in which one or more arteries in the lungs are blocked by a blood clot.
Inari develops catheter-based technologies for the treatment of venous thromboembolism, which causes blood clots to form, most often in the leg, groin or arm, then break loose and travel in the blood. The condition becomes pulmonary embolism when the clot moves to the lungs.
“The FlowTriever System is an exciting advancement in the treatment of acute pulmonary embolism patients,” said Dr. Wissam Jaber of Emory University Hospital in Atlanta, Ga. He’s a principal investigator of the device’s recent 106-patient, 18-site clinical study, which provided results for the clearance.
“Until now, there has not been an approach to rapidly restore flow to reserve the right heart strain without the use of thrombolytic drugs and their inherent risk of bleeding complications,” he said.
The company said the product is “the first and only thrombectomy device cleared by the FDA for the treatment of [pulmonary embolism].”
Its portfolio also includes the ClotTriever System, which received FDA clearance in February 2017.
Inari, founded in 2013, is a spinoff of medical device incubator Inceptus Medical LLC in Aliso Viejo. The device maker is backed by European healthcare investor Glide Healthcare, healthcare investment firm Versant Ventures and U.S. Venture Partners, as well as its founders and other private investors.
Meanwhile, Irvine-based Branchpoint Technologies announced it got FDA clearance for its Aura ICP Monitoring System, which provides intracranial pressure monitoring. Aura is a fully implantable and wireless intracranial pressure sensor used to monitor brain-injured patients.
The company said that unlike traditional monitoring systems that require a cabled connection with the patient’s brain, Aura’s wireless design allows continuous telemetric monitoring of intracranial pressure while eliminating the need for additional capital equipment investments.
“With traditional [intracranial pressure] monitoring systems, patient mobility within the hospital is cumbersome and product dislodgement and malfunction is common,” said Dr. Michael Muhonen, director of neurosurgery and medical director of the neuroscience institute at Children’s Hospital of Orange County. He said Branchpoint’s device not only solves those problems, it also has the potential to be used “in combination with a shunt to provide better hydrocephalus management.”
Mix Work, Play
The growing popularity of wearable fitness trackers offers more opportunities for wearable devices to monitor and record health data. Irvine-based noninvasive patient monitoring device maker Masimo Corp. is joining the game via its partnership with the St. Petersburg, Fla.-based Women’s Tennis Association.
The association announced its sports sciences and medicine team will use MightySat to provide comprehensive care for its athletes. The fingertip pulse oximeter measures oxygen level in the blood, pulse rate and strength, respiration rate, and pleth variability index, which can indicate changes in hydration, breathing effort and other metrics.
The technology displays all noninvasive measurements in real time. Users, in this case the association’s primary healthcare providers—licensed therapists and certified athletic trainers—can also display and track data through the Masimo Personal Health app for Apple and Android.
MightySat is intended for general wellness and health applications. The company offers MightySat Rx for medical professionals.
Shares of the company recently traded at $100 each for a nearly $5.2 billion market cap.
Tapping Philanthropy
The Mission Hospital Foundation, which helps raise funds for Mission Hospital, named John Miller chief development officer, overseeing all aspects of fundraising.
“Philanthropic support of our community is more important than ever as we continue to advance our programs and services,” said Mission Hospital Chief Executive Tarek Salaway.
A top philanthropic priority for the hospital is development of the Judi and Bill Leonard Institute for Cancer Prevention, Treatment and Wellness. The four-story, 104,500-square-foot cancer center received about a $20 million naming gift in March from Judi and William “Bill” Leonard. The outpatient center, slated to be finished next year, is comprised of a 50-50 joint venture between Mission Hospital and senior housing-focused real estate investment trust Welltower Inc. (NYSE: HCN). It’s at the Shops at Mission Viejo, a Simon Property Group Inc.-owned (NYSE:SPG) mall.
Other philanthropic initiatives include further development of the hospital’s other clinical institutes: heart and vascular, mental health and wellness, neuroscience, orthopedics, trauma and emergency, and women and infants.
The 552-bed, acute-care regional medical center is part of Renton, Wash.-based Providence St. Joseph Health’s 14-hospital Southern California network based in Irvine.
Miller previously led large fundraising teams at Pepperdine University, the University of California-Los Angeles and most recently Saint John’s Health Center in Santa Monica, a member of Providence.
