The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

Mardil Medical is developing an investigational device for functional mitral regurgitation
intended to provide ventricular support with adjustable inflatable chambers to reduce annular
dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation.
In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular
and ventricular changes that occur when strategically positioned external inflatable chambers
are applied to the outside of the heart. Favorable benefits of circumferential reduction in
ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV
segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil
Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and
Geometric Changes using the Bladder on a Stick System (BOSS).

Inclusion Criteria:

- Adults ≥18 years of age

- Patient undergoing open chest cardiac surgery via sternotomy

- Signed informed consent by patient or legally authorized representative

Exclusion Criteria:

- Any procedure, condition or cardiac anatomy that may impact or compromise the
pericardial space (e.g. prior valve surgery, CABG, epicardial pacing leads,
pericarditis, history of mantle radiation, or other procedure involving pericardial
access)