A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

Pulnovo Medical Announced Results From PADN-CFDA Pivotal Trial

For The Treatment Of Pulmonary Arterial Hypertension (PAH) Meet The Efficacy Primary Endpoint

What To Know

  • Stone, TCT Conference Chairman and one of the world’s leading cardiovascular experts, announced that he will lead a group of global pulmonary hypertension and cardiovascular experts to launch a pivotal trial in 2022, being the first global PADN multicenter pivotal trial.
  • PADN is an innovative radiofrequency ablation technique in treating PH, was recognized as a CFDA innovative medical device in 2018, and designated as a “breakthrough device”.

Pulnovo Medical Limited, a globally recognized device pioneer in treatment for cardiopulmonary disease, today announced the positive results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study, being the first global completed pulmonary hypertension treatment device RCT study. PADN is an innovative radiofrequency ablation technique in treating PH, was recognized as a CFDA innovative medical device in 2018, and designated as a “breakthrough device” by the US FDA in 2021. The data from the PADN-CFDA pivotal study meet the primary efficacy and safety endpoint.

About Pulmonary Hypertension

Pulmonary Hypertension is defined as an increase in mean pulmonary arterial pressure (PAPm) ≥25 mmHg at rest as assessed by right heart catheterization (RHC), caused by different etiologies, which eventually lead to the right heart increased load, right heart failure and sudden death. The term PAH describes a group of PH patients characterized hemodynamically by the presence of pre-capillary PH, defined by a pulmonary artery wedge pressure (PAWP) ≤15 mmHg and a PVR.

As a pathological phenomenon, pulmonary hypertension includes a variety of diseases, such as left heart disease, lung disease, chronic pulmonary thrombosis and others. Many has considered PH as the “cancer” of cardiovascular disease, due to its low chance of survival rate. Without proper treatment, the average life span of patients is estimated to be 2.8 years.Previously, the existing treatments for patients with pulmonary hypertension mainly relied on targeted drugs and lung transplantation.

About PADN

PADN is a potential global first-in-class, best-in-class innovative radiofrequency ablation device in treating PAH. It was designated as a “breakthrough device” by the US FDA in 2021. PADN is a vascular interventional ablation that uses radiofrequency ablation to block the pulmonary intima sympathetic nerve and reduce pulmonary artery pressure to delay disease progression.

Because of its pioneering nature, PADN has captured the attention from the medical experts from the cardiovascular and respiratory field.  During the 2021 Transcatheter Cardiovascular Therapeutics Conference, Dr. Gregg W. Stone, TCT Conference Chairman and one of the world’s leading cardiovascular experts, announced that he will lead a group of global pulmonary hypertension and cardiovascular experts to launch a pivotal trial in 2022, being the first global PADN multicenter pivotal trial.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).
“Tom and I have more than 50 years of experience,” Harp adds. “The decision to found Polymer Medical was done after careful consideration of the landscape and market opportunity; we will raise the level of competition and quality for customers.” Polymer Medical is located in a newly refurbished plant is at 168 Thorn Ave., Orchard Park, N.Y.
The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations.
Details of the session: Polaroid Therapeutics & Avery Dennison Medical: How the power of partnership brings a novel approach to antimicrobial wound dressings.
SABIC advises the project was initiated together with the dialysis department at Jessa Hospital, one of the largest non-university medical cluster in the Limburg region of Flanders, Belgium.

By using this website you agree to accept Medical Device News Magazine Privacy Policy