First Patient Enrolled in STTAR Study's Transcatheter Arm of Micro Interventional Devices' Annuloplasty Technology

October 12, 2018—Micro Interventional Devices, Inc. announced the first percutaneous implantation of the company's minimally invasive annuloplasty (MIA) technology for tricuspid and mitral repair. The procedure marked the beginning of enrollment in the transcatheter arm of the STTAR trial being conducted in Europe.

The STTAR study has two arms: a surgical arm and a percutaneous arm. This is the first of 40 patients to be enrolled in the percutaneous arm of the STTAR multicenter clinical trial. The company now has 1-year follow-up data on three patients in the surgical arm, confirming that the reduction in tricuspid regurgitation (TR) and tricuspid annular dimensions observed acutely are maintained at 1 year. The team anticipates that enrollment in the percutaneous arm will move quickly given the short learning curve associated with the technology.

The percutaneous bicuspidization was performed on a female patient who was 61 years of age with severe torrential TR. Physicians used a 12-F MIA delivery catheter and the company's PolyCor anchors to successfully reduce tricuspid annular dimensions and TR in the patient.

According to the company, the procedure reduced the dilated tricuspid annulus (TA) by 29%, from 20.9 cm² to 14.9 cm². Additionally, treatment with the MIA device resulted in a 36% reduction in effective regurgitant orifice area, from 2.5 cm² to 1.6 cm². There were no reported complications or adverse events. The image-guided procedure relied on fluoroscopy and three-dimensional echocardiography to accurately place the PolyCor anchors on the TA. MIA's PolyCor anchoring technology enables the percutaneous bicuspidization of the tricuspid valve, replicating an open surgical bicuspidization procedure.

The procedure was performed by a team lead by Prof. Audrius Aidietis, MD, Chief of Cardiology and Angiology, and Prof. Kestutis Rucinskas, MD, Chief of Cardiac Surgery at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania. Proctoring the case were Mathew Williams, MD, Director of the Heart Valve Program, and Alan Vainrib, MD, a cardiologist and echocardiography specialist, both from NYU Langone Health in New York, New York.

In the company's announcement, Prof. Aidietus commented, "The percutaneous MIA system has the potential to be a safe and effective intervention for patients with moderate to severe TR."

Prof. Rucinskas added, "I expect the reduction in TR and annular area achieved during this procedure to improve the patient's symptoms, resulting in favorable right ventricular remodeling. We look forward to continuing to enroll patients in STTAR to assess the safety and performance of this new therapy."