HeartWare’s still chasing PMA, more study results on the way

Heartware's still chasing PMA for destination therapy, more study results on the way

Framingham, Mass.-based medical device company HeartWare International (NSDQ:HTWR) hopes its newly approved cohort of heart pump clinical trial patients will help quell concerns about "neurological events" associated with its implant in earlier studies.

North Carolina cardiologist Dr. Joseph Rogers, a principal investigator for HeartWare’s ENDURANCE trial, told reporters that he plans to submit the latest clinical findings for presentation at the 2014 American Heart Assn. meeting or the subsequent meeting of the American College of Cardiology, including both the original patient cohort as well as the supplemental cohort that is receiving blood pressure management in addition to the implantable heart pump.

The ENDURANCE trial hit a speed-bump early on when researchers noted an unexpectedly high rate of ischemic and hemorrhagic strokes in HeartWare patients (6.7% and 5.1% respectively), as compared to a control pump (4.3% and 0%, respectively). Those findings prompted the FDA to take a peek at HeartWare’s interim results, and the company eventually targeted blood pressure management as a potential avenue for stemming further adverse events, TheHeart.org reported.

Asking for those interim results was "a very unusual request from the FDA," Rogers told the news source, "but it is what it is."

"There was a question of whether the adverse-event rate for neurological events was higher with HeartWare, so that’s what prompted the company to go back into the data set and identify factors that may be associated with that, and one of the factors that came out was high blood pressure," he added.

In June 2013 the FDA granted HeartWare conditional approval for another 360-patient cohort, expanding the original ENDURANCE trial to evaluate the effect of closer blood pressure monitoring on neurological events. At the time, HeartWare said that the new study aimed to "confirm observations from Endurance that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events."

Rogers hopes to use data from both the original and the expanded cohort of patients to draw conclusions about patient outcomes with the heart pump as a destination therapy, but combining the data could mean diluting important warnings.

"This field is still in its relative youth, and there are things we don’t know about the pumps," he told The Heart. "We were assuming that those 2 pumps we were testing in ENDURANCE are the same, and they are not, they are very different pumps. So it may be that BP management is more important with one than the other."

HTWR shares were flat at $80.21 as of about 12:50 p.m. today, still trending downward overall since the company released a mixed Q2 earnings report earlier this month. The company came under pressure after it missed Wall Street’s loss-per-share forecast on lower-than-expected U.S. sales of its implantable heart pump during the 2nd quarter.

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply