Abbott launches pivotal US-based Tendyne TMVR trial

Abbott (NYSE:ABT) said today it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation.

In the trial, the Abbott Park, Ill.-based company will explore the safety and efficacy of the system in treating patients with mitral regurgitation. Abbot touted the Tendyne as the first and only mitral valve replacement designed to be retrievable and repositionable.

“Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve instead of repair. Abbott established the market for minimally invasive mitral valve repair with MitraClip, showing the safety and viability of a non-surgical repair and paving the way for other catheter-based devices to treat structural heart diseases. Our scientists and engineers are building on our expertise to advance transcatheter mitral valve replacement with our Tendyne technology to provide a needed treatment option,” Abbott structural heart biz VP Michael Dale said in a press release.

In the Summit study, investigators look to enroll 1,010 patients at 80 sites across the US, Canada and the EU exploring the safety and efficacy of the device in treating severe MR. Dr. Jason Rogers of Sacramento’s U.C. Davis Medical Center and Dr. Gorav Ailawadi of the University of Virginia will serve as co-principal investigators of the study, Abbott said.

The first patients in the trial have already been treated at Wichita, Kan.’s Ascension’s Via Christi Hospital St. Francis and Morgantown’s West Virginia University Heart and Vascular Institute, Abbott said.

“The mitral valve is known for its complex anatomy and, as a result, managing mitral regurgitation can be challenging, especially in elderly or frail patients for whom there are limited to no treatment options. I’m encouraged by promising early results from the global study and excited about the potential for the Tendyne device to advance the field of transcatheter mitral valve replacement in the U.S. by providing another option for MR patients needing a minimally invasive alternative,” Via Christi structural heart program medical director Dr. Bassem Chehab, who implanted the first patient in the Tendyne valve study, said in a prepared statement.

Abbott said it is also launching a separate feasibility study of the Tendyne system in patients with severe mitral annular calcification.

The launch comes only a week after investors in Tendyne Holdings filed a suit against Abbott over a $50 million milestone payment, alleging that the healthcare giant dragged its heels on obtaining a regulatory approval that would have triggered a $50 million milestone payment.

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