Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension - Business Wire

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Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension - Business Wire Posted: 06 Feb 2020 04:00 AM PST SAINT PAUL, Minn.--(BUSINESS WIRE)--Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases. BDP is intended to help patients gain faster access by expediting designated device development, assessment, and review, while preserving the statutory standards for premarket approval, consistent with the FDA's mission to protect and promote public health. "Despite the availability of multiple drug therapies, pulmonary hypertension remains a disease with large, unmet needs. Aria's device-based solution has the potential to treat this disease more effectively and with fewer side effects, and the Breakthrough designation provides the opportunity for earlier access to patients," said Gregg W. Stone MD, Director of Academic Affairs for Mount Sinai Heart Health System and a member of Aria's Scientific Advisory Board. PAH is a progressive, highly debilitating disease that may lead to heart failure. The implanted Aria CV PH System is designed to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow. These benefits have the potential to improve both duration and quality of life. "The FDA's designation of the Aria CV PH System as a Breakthrough Device affords multiple potential benefits to the company including flexible clinical trial design and facilitated patient access through CMS's revised reimbursement pathway. Our mission is to address the unmet clinical need for this life-threatening disease with an effective treatment option and this designation brings us one step closer to delivering on this mission," said Dan Gladney, CEO and President of Aria CV. About Pulmonary Hypertension Pulmonary hypertension is characterized by high blood pressure in the arteries of the lungs, a condition which causes increased workload on the heart, leading to right heart failure. In a common form of the disease, pulmonary arterial hypertension affects mostly women often in the prime of life. Even with currently approved therapy, it is considered a deadly progressive disease. About Aria CV, Inc. Based in St. Paul, Minnesota, Aria CV was founded in 2010 by Drs. John Scandurra and Karl Vollmers, following development work the two had done at the University of Minnesota's Earl E. Bakken Medical Devices Center. Aria has performed a successful acute first in human clinical study in Vienna, Austria and is now preparing for a U.S. clinical trial under FDA's Early Feasibility Study Program to evaluate long term implants in PAH patients. Aria CV's major shareholders include Catalyst Health Ventures, Broadview Ventures, Biostar Ventures and a strategic investor.

Elevated pulmonary vascular resistance increases mortality risk after heart transplant - Healio Posted: 15 Jan 2020 12:00 AM PST Even with lower pulmonary artery pressures, elevated pulmonary vascular resistance is associated with worse survival after heart transplant, according to a recently published study. Whereas pulmonary hypertension was previously defined as a mean pulmonary artery pressure (mPAP) of at least 25 mm Hg, the definition was revised at the 6th World Symposium on Pulmonary Hypertension to lower the mPAP threshold to greater than 20 mm Hg in the setting of pulmonary vascular resistance greater than three Wood units. "How this definition impacts World Health Organization group 2 pulmonary hypertension (pulmonary hypertension due to left heart disease), and specifically the relevance of lower pulmonary artery pressures in the hemodynamic assessment of cardiac transplant candidates, is largely unknown," Todd C. Crawford, MD, from the division of cardiac surgery at Johns Hopkins University School of Medicine, and colleagues wrote. Using the United Network for Organ Sharing database, the researchers identified adults who underwent heart transplantation from 1996 to 2015 and categorized them as having mPAP less than 25 mm Hg or mPAP of 25 mm Hg or greater. Primary outcomes included survival at 30 days and 1 year, which was conditional on survival at 30 days. From 1996 to 2015, 32,465 patients underwent heart transplantation. Of these, 38% had mPAP less than 25 mm Hg and 62% had mPAP of 25 mm Hg or greater. Among those with lower mPAP, the median age was 55 years and the median pulmonary vascular resistance was 1.5 Wood units. Even with lower pulmonary artery pressures, elevated pulmonary vascular resistance is associated with worse survival after heart transplant, according to a recently published study. Source: Adobe Stock Among patients with lower mPAP, pulmonary vascular resistance was still linked to an increased risk for death at 30 days after transplant (HR = 1.16; 95% CI, 1.05-1.27) after adjustment for recipient-, donor- and transplantation-related confounders. However, it remained unassociated with 1-year conditional mortality (HR = 1.03; 95% CI, 0.94-1.12). Additionally, an absolute increase in 30-day mortality of 1.9% was noted with pulmonary vascular resistance of three Wood units or greater among patients with mPAP less than 25 mm Hg, which was similar to that observed among patients with pulmonary vascular resistance of three Wood units or greater and higher mPAP. "In conclusion, increasing pulmonary vascular resistance in heart transplant recipients with mPAP < 25 mm Hg is associated with statistically significantly worse early survival after transplantation, and clinicians should not be reassured by normal or near normal pulmonary pressures alone," the researchers wrote. "The absolute increase in risk may not be prohibitive and is similar in magnitude to other comorbid conditions in heart transplantation, but should be considered in the overall assessment of candidacy." They also noted that these findings lend support to the change in definition of pulmonary hypertension that now incorporates lower pulmonary pressures in the setting of elevated pulmonary vascular resistance. – by Melissa Foster Disclosure s : Crawford reports he received funding from the Hugh R. Sharp Endowed Fellowship. Please see the study for all other authors' relevant financial disclosures.

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