Valcare Medical has announced the US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to commence an early feasibility study (EFS) for the Amend transseptal system.
The Amend transseptal system is a transcatheter device intended for treatment of mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring that mimics today’s surgical gold standard.
The EFS will evaluate the safety and functionality of the Amend transseptal system in the treatment of subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) that are anatomically suitable for transcatheter mitral annuloplasty. The EFS will enrol up to 15 subjects in seven investigational centres in the USA. The study is expected to begin treating patients in the first half of 2025, paving the way for a pivotal study anticipated in 2027.
The primary and secondary endpoints of this trial include safety and device performance assessments such as technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes such as stroke, myocardial infarction (MI), non-elective cardiovascular surgery for device related complications, and all-cause mortality are to be reported at 30 days and six months post implantation.
Additional secondary endpoints will include changes in New York Heart Association (NYHA) functional class, six-minute-walk-test, quality of life at 30 days and six months in addition to reduction of MR grade from baseline by at least 1 grade at 30 days, six months and one year.
“I am pleased and eager to begin the Amend transseptal system EFS to further evaluate this promising novel technology. The Amend annuloplasty ring has the potential to improve mitral repair for a patient population that are considered poor candidates for currently available therapies,” stated Scott Lim (University of Virginia, Charlottesville, USA), AMEND EFS study chairman. “Furthermore, the AMEND system provides a non-invasive approach to the gold standard surgical repair, and I am excited for its potential to treat patients suffering from severe mitral regurgitation.”
“The FDA’s approval to begin the Amend EFS is a critical milestone for Valcare Medical on the path to achieving eventual premarket approval in the USA,” said Steve Sandweg, president and chief executive officer for Valcare Medical. “I am incredibly proud of the entire Valcare Medical Team for achieving this important milestone.”
