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MEDICAL DEVICE NEWS MAGAZINE

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Biotechnology News Magazine

Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study

Amended study design provides immediate access and clinical benefits for all patients and becomes the first global IDE study for PA pressure-guided heart failure management

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Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor1, shifting the design from a randomized control study to a single-arm study.

Following the 2021 update to the 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment and the recently presented GUIDE-HF data, the FDA’s decision underscores the clinical benefits of PA pressure-guided HF management for New York Heart Association (NYHA) class III heart failure patients2,3.

The new PROACTIVE-HF trial design ensures the over 100 previously enrolled patients have immediate access to the proven clinical benefits of PA pressure-guided therapy and expands the study to include clinical sites across Europe, as well as the U.S. The company is currently implementing the updated PROACTIVE-HF study design at trial sites worldwide.

“The FDA’s decision to approve the amended study design further validates what we are seeing in clinical practice. PA pressure-guided heart failure management is quickly becoming standard of care for NYHA class III patients based on the growing body of evidence supporting this approach,” commented Dr. Liviu Klein, Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension and Heart Transplant at UCSF and National Principal Investigator of the PROACTIVE-HF trial. “Understanding changes in PA pressure data is key to properly implementing guideline directed medical therapy and keeping these patients out of the hospital. The Cordella HF System and Sensor offers the next gen technology in PA pressure sensing and will play a critical part in how heart failure patients are managed moving forward.”

The single-arm study design maintains similar safety and efficacy endpoints as the original study design, with the primary efficacy endpoint designed to demonstrate low rates of all-cause mortality and HF hospitalizations in the high-risk NYHA class III patient cohort. Under the updated study design, the PROACTIVE-HF trial will enroll over 400 NYHA class III patients at more than 100 sites worldwide. The trial is expected to complete enrollment in the second half of this year.

“The FDA’s decision is great news for our PROACTIVE-HF study patients – they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Furthermore, it is an important acknowledgement for the therapeutic category and the benefits that PA pressure-guided heart failure management enables,” stated Harry Rowland, CEO of Endotronix. “Our team and clinical partners have been energized by the announcement and it obviously has a significant impact on our ability to bring the Cordella Sensor to market sooner in the U.S. and Europe.”

Executives

Jill Canada Appointed VP of Corporate and Enterprise Sales at Avail Medsystems

With Ms. Canada's hire, Avail furthers its continued organizational expansion including moving from a business incubator into a larger headquarters in May 2021, a $100 million Series B funding round, the ongoing expansion of contracts with medical device industry clients, and the addition of console locations across the US.

Richard John Daly Appointed President of CARsgen Therapeutics Corporation

Mr. Daly brings approximately 30 years of experience in pharmaceutical industry, including leadership positions in multi-national corporations and biotech companies. Prior to joining CARsgen, Mr. Daly served as Chief Operating Officer of Beyond Spring, Inc.

Getinge appoints Patricia Fitch as President North America Region

Patricia Fitch joined Getinge in March 2021 as Vice President US Sales covering the Acute Care Therapies division. Patricia has more than 30 years of...

FDA Updates

Endomina System, a New Suturing Tool for Use by Gastroenterologists Receives FDA Clearance

“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” said Dr Ivo Boškoski from Policlinico Gemelli, Rome, Italy.

VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System

VUZE Medical, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance...

FDA Approves Cochlear Nucleus Implants for Unilateral Hearing Loss/single-sided Deafness

Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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AtriAN Medical’s Clinical Data Update on the Neural AF Multi-center Study

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Other News

Endomina System, a New Suturing Tool for Use by Gastroenterologists Receives FDA Clearance

“This technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,” said Dr Ivo Boškoski from Policlinico Gemelli, Rome, Italy.

ACI Donates 500,000 N95 Respirators to Project N95

“Throughout this pandemic our focus has been on protecting healthcare workers and our general population by providing an affordable, quality American-made N95 for as many Americans as possible.