Planned Pivotal Trial for PADN Device for PAH

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    • #35210
      Jen Cueva
      Keymaster

      Yesterday I read this PH News news story about a new planned pivotal trial of the PADN device.

      Pulnovo Medical reported that it “successfully concluded” a first meeting with the U.S. FDA regarding the design of a pivotal clinical trial of its pulmonary artery denervation (PADN) device in people with PAH.

      Here are some of the highlights:

      * Could lower pulmonary pressures
      * May delay progression
      * Follows a clinical trial in China
      * Improved exercise capacity and physical functioning
      * Designated as a breakthrough device

      What takeaways do you have after reading?

    • #35362
      Carol Volckmann
      Participant

      Hi Jen,

      For some reason the forum and PH news all go into trash and I forget to look there as to what’s on the forums.

      This article sure looks like a device blocking the nerves via radio waves that a Chinese lab was trying several years ago, but failed as it burned through the nerves. I have reached out to my Pulmonologist to ask as he was in China looking at this several years ago. But, he is out of the office till next week. I will be in touch as soon as I have talked to him.

      I also missed the whole story regarding Kakes reaching out to the forum about her sister Kesia. I am so impressed as to the many people out there reaching out with help, support and love – it brought me to tears.

      You and Colleen really make it all happen and all of us react to that positive attutude, support and love.

      This is a journey we all are on – some would say we are all in the same boat. We really are not – each of us have different issues we have to deal with in our own boat but we can say we are all in the ocean!

      Be well be safe and THANK YOU for all you do! Lots of hugs filled with ❤ 😍

      • #35370
        Jen Cueva
        Keymaster

        Hi there, sweet PHriend @cdvol3gmail-com; I’m sorry that your notifications are going into your trash. If you can, add [email protected] to your address book and see if this helps with that. We hate you’re missing so much of the conversation. And I thought you were resting.

        Please let us know what your doctor says and if this is the device he was looking into.

        Thank you for such heartfelt words; I’ve been brought to tears several times just this week by the love and support the forums offer. We are grateful, but it wouldn’t be what it is without each of you and sharing your love, support, and journeys with all.

        I love your mindset about being different boats in the same ocean. That sounds like a nice place to be, in the ocean meeting up with y’all on our boats and hanging out. I can picture it now, as I know you love the water, and I do, too.

        Take care of yourself, and I hope you and Dick have a nice relaxing weekend. Keep cool in that heatwave. Hugs and love are coming your way from San Diego.

        Your words mean so much; thanks for sharing and being so thoughtful. You all are the true MVPs.

        • #35372
          Carol Volckmann
          Participant

          Hi sweet friend,

          I added [email protected] … to my contacts and it works, thanks.

          I did get an email back from my Pulmonologists re PADN, and yes he was in China in 2013 looking into this and the outcome was not good, but he is aware of the new developments and will keep me posted.

          I found another medical research – Swedish- that uses ultrasound not radio waves and they were looking at the US for trials but because of covid they have put it on the back burner. I put them in touch with my Pulmonologist at UW and they have stayed in touch. So … it is a wait and see.

          For PH patients that are on subQ or Hickman line, it would be a real game changer!

          Accirding to Peter the PADN is a bit more complicated and not as user friendly as using ultrasoud. So, we shall see.

          Here on the Peninsular we have not been hit by the heat wave – highs only low 80s and cool nights. Seattle and the mainland has been HOT – I hope Colleen and family are staying cool.

          Love and hugs,
          Carol

        • #35373
          Jen Cueva
          Keymaster

          Hey @cdvol3gmail-com, I’m happy that the tip worked.

          Thanks for the update on this device, and we look forward to hearing the updates from your doctor.

          The ultrasound waves certainly sound like a game changer and would be less invasive. Thanks for sharing such developments with us all. Please share any time you read about new developments and research in PH.

          Wow, your heat wave is like here, maybe 80 or high 70’s. Certainly, Colleen and her fam in the Seattle area are getting much heat. I know she’s trying to keep cool. They need to go over to the island and see if you get some cooler air.

          Take care and enjoy your weekend. I’ll pick my niece up from the airport this afternoon and spend time with her. So Auntie Jen is super excited to spend time with her before heading to college.

        • #35374
          Carol Volckmann
          Participant

          I just went on the site for the ultrasound device for PH. sonivie.com then click on News.

          I had forgotten it is an Israeli corp. Their US office is in NJ.

          The news item – they successfully used this on a patient May 2022.
          It is all really interesting.

          As Peter said I may be too stable for them to put me in their trials.

          I am staying on top of these companies and as I learn more I will put it out there.

    • #35389
      Jen Cueva
      Keymaster

      Excellent; thanks so much, @cdvol3gmail-com, for sharing this news with us. I know we all want to learn about the latest research and developments in the PH community.

      Yeah, but being “stable” is also a positive, too. I’m probably too stable for most, too. That and my kidney disease now often exclude me from many clinical trials.

      Have y’all read through inclusions and exclusions for clinical trials? Some are quite the lengthy read.

    • #35392
      Carol Volckmann
      Participant

      Hey Jen, you’re right, I am also too stable for these trials and having Scleroderma excludes me as well. The other issue is not knowing if you are on the placebo. I do still keep looking… I sure hope your kidney are under control! 😊❤

    • #35395
      Jen Cueva
      Keymaster

      Thanks so much for the love and support, @cdvol3gmail-com. Yes, ma’am, my kidneys are doing all right. They are holding their own, I guess, for the most part.

      Finding a balance between my fluids and electrolytes is a struggle that has been ongoing for a few years. “No Biggie,” as my late Pawpaw would say.

      One day at a time, my sweet PHriend.

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