Ancora Heart’s AccuCinch ventricular restoration system wins FDA breakthrough nod

[Image from Ancora Heart]Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system.

Santa Clara, California-based Ancora Heart designed its AccuCinch system to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). The company is currently evaluating the system in the Corcinch-HF pivotal clinical trial.

According to a news release, as the only completely transcatheter procedure for treating the enlarged left ventricle, AccuCinch offers a fundamentally different and innovative device-based therapy for improving the structure and function of the heart, helping to bring relief to HF patients who remain symptomatic despite current guideline-directed medical care.

“The chronic and progressive nature of heart failure leaves many patients to face an increasingly challenging future as existing treatments, inclu…

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MedTech 100 roundup: Return to normal after last week’s spike

After rising more than 31 points to heights never before reached, the medtech industry returned to normal this past week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 23) at 115.54 points, a total that, had it not been for last week, would be the index’s all-time high.

However, the index finished the previous week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception — and perhaps an anomaly. Although the index slid by -20.8%, it remains in a stronger position than ever before, last week notwithstanding.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 25.2% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). It remains well ahead of the mid-pandemic low…

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Ancora Heart raises $80M for ventricular restoration system

Ancora Heart announced today that it raised $80 million in equity financing for its AccuCinch ventricular restoration system.

Santa Clara, Calif.-based Ancora Heart said in a news release that funds raised in the equity round are earmarked for the acceleration of the Corcinch-HF pivotal clinical study of the AccuCinch system for treating symptomatic heart failure with reduced ejection fraction (HFrEF).

The company won FDA investigational device exemption for AccuCinch in June 2020 and began enrolling patients in the pivotal trial in January of this year.

Ancora Heart designed AccuCinch to treat patients with HFrEF by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure. The company touts it as the only completely transcatheter procedure for treating the enlarged left ventricle.

Sands Capital, Sio Capital and an undisclosed strategic investor joined all existing investors f…

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Ancora Heart says enrollment has started for AccuCinch pivotal trial

Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.

AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.

The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Ancora Heart says enrollment has started for AccuCinch pivotal trial

Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.

AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.

The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.

Get the full story on our sister site, Medical Tubing + Extrusion.

Read more
  • 0

Ancora Heart says enrollment has started for AccuCinch pivotal trial

Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.

AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.

The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.

AccuCinch is touted as being one of the only completely transcatheter procedures to treat the enlarged left ventricle. It differs from device-based therapies that are designed to improve the structure and function of the heart to bring relief to heart failure patients who are still symptomatic.

“In patients with heart failure, the …

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Ancora Heart wins IDE for ventricular restoration system

Ancora Heart announced today that it received FDA investigational device exemption (IDE) for its AccuCinch ventricular restoration system.

AccuCinch is designed to treat patients with heart failure and reduced ejection fraction (HFrEF) by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure, according to a news release.

Garnering IDE allows for Ancora Heart to go ahead with its CorCinch-HF pivotal study, which is set to evaluate the safety and efficacy of the AccuCinch system in HFrEF patients.

The prospective, randomized, open-label, multicenter, international clinical safety and efficacy investigation of the AccuCinch system is set to enroll 400 patients at up to 80 centers worldwide. It allows for initial analysis for premarket approval submission after the first 250 patients reach six months of follow-up, then a second analysis after the entire cohort reaches 12 months. The s…

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