Irvine-based Masimo Corp. has had a busy May.
The maker of patient monitors received Food and Drug Administration approval for one of its products, signed a big overseas contract, and got its technology validated in a pair of professional journals.
It started with the FDA clearing Masimo’s rainbow Acoustic Monitoring sensor for assessing pediatric patients’ breathing.
A few days later came a deal with Turkey-based Uludag University Hospital to place the Masimo SpHb noninvasive, continuous hemoglobin tracking device in the 880-bed facility.
Masimo said in a release that the Uludag deal represented its largest full technology installation in Turkey to date.
SpHb is part of Masimo’s SET pulse oximetry line.
Dr. Gulsen Korfali, chairman of Uludag University’s department of anesthesiology and reanimation, said in a press release that Masimo SET “has tremendously reduced our sensor consumption because they last longer. We used to discard sensors every day.
“Now we can use a sensor for up to five days,” Korfali said. “We also have almost no false alarms and a higher ability to detect desaturations with Masimo SET in our critical care areas.”
Chicago-based Zacks Investment Research cited the deal in Turkey in a research note: “Uludag University Hospital is one of only two hospitals in Turkey with accreditation from Joint Commission International,” Zacks said, adding that Uludag is gaining “from lower sensor usage and better detection ability.”
Zacks said that, while SpHb and other rainbow measurements can drive growth of sales to hospitals for Masimo, there are some concerns about the company, including what it called a reliance on sales to original equipment manufacturers and group purchasing.
Original equipment manufacturers accounted for 15% of Masimo’s $135.9 million in first-quarter revenue.
“Additionally, we remain concerned about its reliance on group purchasing organizations for the sales of its pulse oximetry products to hospitals in the domestic market,” Zacks said.
Separately, Masimo said a new study in the British Journal of Anaesthesia showed that its noninvasive PVI monitor could be used to help doctors accurately assess fluid response in children who are under general anesthesia.
The journal published results from a South Korean study evaluating 33 children ages 6 months to 9 years old who were undergoing neurosurgery.
The study looked at whether the patients would benefit from fluid administration when necessary in order to enable organ preservation.
“As previous studies have shown with adult patients, this study demonstrates that PVI monitoring can non-invasively and continuously assess fluid status in children and be more effective than common invasive technologies and is similar to newer, costlier techniques,” Dr. Michael O’Reilly, Masimo’s chief medical officer, said in a news release.
Masimo later said that a study due to be published in Anesthesia & Analgesia, a U.S. medical journal, concluded that its rainbow Acoustic Monitoring device more “accurately, precisely and reliably” detected ventilator pauses in post-surgical patients as compared to capnometry, which involves measuring carbon dioxide in respired gases.
The study covered 33 adult post-surgical patients monitored at the Baylor University Medical Center’s post-anesthesia unit in Dallas.
Masimo said continuous monitoring of patients’ respiratory rates was “especially important” for such patients who receive sedatives, opioids, or patient-controlled analgesia for pain management because sedation could induce respiratory depression and place them at “considerable risk of serious injury or death.”
Direct Flow’s Clinical Trial
Direct Flow Medical Inc., a Northern California medical device maker with a manufacturing hub in Lake Forest, said the Food and Drug Administration has approved its request for an investigational device exemption.
That will allow Direct Flow to start a feasibility trial for its transcatheter aortic replacement heart valve.
Direct Flow’s valves are used to treat patients with severe aortic stenosis, or a narrowing of the arteries.
The device maker touts its valve as different from other less-invasive models, such as the Edwards Sapien by Irvine-based Edwards Lifesciences Corp.; CoreValve, from Minnesota-based Medtronic Inc.; as well as Portico, a recently approved valve by St. Jude Medical Inc., another Minnesota device maker with Orange County operations.
Direct Flow bills the flexible design of its valves as a key to eliminating aortic regurgitation, which can cause complications in surgery.
The company’s trial will have 30 patients at up to six domestic clinical sites.
Direct Flow received European regulatory clearance in January and now sells its valve there.
Bits and Pieces:
CalOptima, an Orange-based county organized health system, hosted a legislative update last week that touched on healthcare issues and related topics, as well as the impact of Gov. Jerry Brown’s recently revised budget proposal.
The forum featured Michael Schrader, CalOptima’s chief executive, as well as several other CalOptima officials. … Aviir Diagnostic Laboratories Inc. of Irvine said its MI5 predictive test was used by San Clemente-based Kagan Publishing and Professional Development’s workforce in order to assess their heart health.
