Technology | Heart Failure | July 30, 2019

Procyrion Receives FDA Breakthrough Device Designation for Aortix System

Resting the heart while perfusing the kidneys, Aortix aims to treat heart failure symptoms by disrupting the cardiorenal syndrome cycle

Procyrion Receives FDA Breakthrough Device Designation for Aortix System

July 30, 2019 – Procyrion Inc. secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Aortix System. Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.

Breakthrough Designation is granted to certain medical devices and device-led combination products that provide a more effective treatment of life-threatening or irreversibly debilitating diseases. It enables manufacturers to provide patients and healthcare providers with timely access to medical devices by expediting their development, assessment and review. Benefits of this designation include frequent interactions and feedback from FDA during the premarket review phase. Through this program, Procyrion can expect prioritized review of its FDA submissions for the Aortix System. In addition, the Centers for Medicare and Medicaid Services (CMS) recently proposed a new rule1 that would provide coverage and increase payments for medical devices designated by the FDA as breakthrough devices, so Medicare beneficiaries do not have to wait for access to the latest innovations. 

“With Aortix, we have a device innovation that truly warrants breakthrough designation for the treatment of ADHF patients with worsening renal function, a particularly challenging group of patients for whom outcomes are generally poor and treatment options limited,” commented Keith Aaronson, M.D., MS, Pitt Collegiate Professor of Cardiovascular Medicine and medical director of the Center for Circulatory Support at the University of Michigan.

Heart failure (HF) is common, affecting more than 6 million adults and resulting in more than 1 million annual hospitalizations in the United States alone.[2]  HF costs the nation an estimated $30.7 billion each year.[3] HF is a chronic, progressive condition, marked by episodes of acute decompensation typically requiring hospitalization for stabilization and improvement in symptoms. Unfortunately, outcomes after hospitalization for decompensated heart failure are poor. The one-year mortality rate after a heart failure hospitalization has remained high at 20-30 percent,[4] and there is additive risk with each subsequent hospitalization.[5,6] In addition, at least moderate renal dysfunction (Stage III) is present in up to 64 percent of ADHF admissions,[7] and it is estimated that more than 325,000 admissions per year in the U.S. are for patients with ADHF who also have worsening renal function.[8] These patients represent a particularly high-risk population, as they are frequently non-responders to available medical therapy and have poor outcomes. 

The Aortix System is a percutaneous circulatory support device for the treatment of heart failure. The initial version of the Aortix device provides up to seven days of circulatory support for chronic heart failure patients who have been hospitalized for ADHF, have worsening renal function, and are unresponsive to medical management. As demonstrated in animal studies[9] and a six-patient First-in-Human study,[10] Aortix benefits both the heart and the kidneys based on its unique design and placement in the descending thoracic aorta. Aortix can disrupt the harmful cardiorenal cycle in two ways: above the pump, it rests the heart by reducing aortic root pressure (afterload) resulting in increased cardiac output and decreased cardiac work; downstream, it provides increased blood flow to the kidneys resulting in increased urine output and a reduction in fluid overload. The device is placed via a minimally invasive catheter-based procedure that takes less than 10 minutes.

For more information: www.procyrion.com

Related Aortix Content

VIDEO: Advances in Interventional Heart Failure Hemodynamic Support 

Aortix Heart Failure Pump Chosen for TCT “Shark Tank” Competition

Reducing Economic Burden of Cardiorenal Syndrome With The Aortix Pump

 

References:

1. https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-08330.pdf

2. Benjamin, E. J. et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation CIR.0000000000000485 (2017). doi:10.1161/cir.0000000000000485

3. Heidenreich, P. A. et al. Forecasting the Future of Cardiovascular Disease in the United States. Circulation 123, 933–944 (2011).

4. Chen, J., Normand, S.-L. T., Wang, Y. & Krumholz, H. M. National and Regional Trends in Heart Failure Hospitalization and Mortality Rates for Medicare Beneficiaries, 1998-2008. JAMA 306, 1669–1678 (2011).

5. Solomon, S. D. et al. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation 116, 1482–7 (2007).

6. Setoguchi, S., Stevenson, L. & Schneeweiss, S. Repeated hospitalizations predict mortality in the community population with heart failure. American Heart Journal 154, 260–266 (2007).

7. Heywood, J. et al. High prevalence of renal dysfunction and its impact on outcome in 118,465 patients hospitalized with acute decompensated heart failure: a report from the ADHERE database. Journal of cardiac failure 13, 422–30 (2007).

8. Adams, K. F. et al. Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J 149, 209–216 (2005).

9. Shabari, F. et al. Improved Hemodynamics With a Novel Miniaturized Intra-aortic Axial Flow Pump in a Porcine Model of Acute Left Ventricular Dysfunction. ASAIO Journal 59, 240 (2013).

10. Vora, A. N. et al. First‐in‐human experience with Aortix intraaortic pump. Catheter Cardio Inte (2018). doi:10.1002/ccd.27857

Related Content

The Cordella Pulmonary Artery Pressure Sensor System for Heart failure. #AHA19 #AHA
News | Heart Failure | November 21, 2019
November 21, 2019 — Endotronix, a digital health and medical technology company dedicated to advancing the treatment
Heart failure VICTORIA TrIal a success. Dave Fornell
News | Heart Failure | November 21, 2019
November 21, 2019 — Merck announced the results from the Phase 3 VICTORIA Study evaluating the efficacy and safety of
The U.S. Food and Drug Administration (FDA) has granted market clearance for AstraZeneca's dapagliflozin (Farxiga) to reduce the risk of hospitalization for heart failure (HF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Feature | Heart Failure | October 21, 2019 | Dave Fornell, Editor
October 21, 2019 – The U.S.
Research Shows Drug Can Extend Survival Rates for Heart Failure Patients
News | Heart Failure | October 16, 2019
Researchers have shown for the first time in preclinical studies that the drug Aliskiren can delay the progression of...
The COAPT Economic Analysis sub-study found it is cost effective to treat heart failure patients who have severe secondary mitral regurgitation with MitraClip to reduce their MR symptoms. #TMVR #TCT2019 #TCT19

The COAPT Economic Analysis sub-study found it is cost effective to treat heart failure patients who have severe secondary mitral regurgitation with MitraClip to reduce their MR symptoms.

News | Heart Failure | October 04, 2019
October 4, 2019 – Results of a new economic analysis of the COAPT Trial data found that transcatheter mitral valve re
COAPT Trial three-year data show the MitraClip continued effectiveness in heart failure patients with secondary mitral reguritation. #TCT2019 #TCT19 #mitralclip

COAPT Trial three-year data show the MitraClip continues to show safety and effectiveness in heart failure patients with secondary mitral reguritation.

News | Heart Failure | October 03, 2019
October 3, 2019 – The three-year results from the...
Positive Safety, Efficacy Data Reported on AccuCinch Heart Failure Device
News | Heart Failure | September 27, 2019
Ancora Heart Inc. announced results from an interim analysis of heart failure patients treated in the CorCinch FMR...
Max and Debra Ernst Heart Center Opening at Beaumont Hospital, Royal Oak
News | Heart Failure | September 20, 2019
The new Max and Debra Ernst Heart Center at Beaumont Hospital, Royal Oak, Mich., will open Sept. 30. It is dedicated to...
FDA Grants Fast Track Designation for Farxiga in Heart Failure
News | Heart Failure | September 18, 2019
AstraZeneca announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the...
Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Device Clinical Trial

The REDUCE LAP HF-II study will combine Corvia Medical's InterAtrial Shunt Device (IASD), pictured here, with physIQ's continuous monitoring platform to evaluate the device's efficacy in patients with heart failure. Image courtesy of Corvia Medical.

News | Heart Failure | September 12, 2019
Corvia Medical has sponsored and is actively enrolling patients in a heart failure (HF) device trial that, in addition...
Overlay Init