TABLE 2.
Mechanism | Device | Manufacturer | Implant Method | Sheath Size | Device Details | Study Details | EFS | Pivotal | CE Mark | FDA |
---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||
mTEER | MitraClip | Abbott Structural | TFV, TS | 24-F | Recapitulates the surgical Alfieri stitch, creating a biorifice MV that reduces MR. 4 clip sizes. | COAPT (NCT01626079) | X | X | X | |
Pascal | Edwards Lifesciences | TFV, TS | 22-F | 1 clip size. Central spacer reduces central MR. | CLASP IIF (NCT03706833) | X | X | X | ||
Dragonfly | Hangzhou Valgen | TFV, TS | 24-F | 4 clip sizes: 4- to 6-mm width, 9- to 12-mm length | NCT04528576 | X | ||||
TMVR | Tendyne | Abbott Structural | TA | 34-F | Valve seated in an inner frame, which rests within a conformable outer frame. Device is secured by an apical tether. | SUMMIT (NCT03433274) | X | X | ||
Intrepid | Medtronic | TA, TFV, TS | 35-F | Dual construction with a conformable outer stent with flexible brim and a circular inner stent housing the valve | APOLLO (NCT03242642) | X | ||||
Sapien M3 | Edwards Lifesciences | TFV, TS | 20-F | 2-component device: valve implanted within a subannular dock | ENCIRCLE (NCT04153292) | X | ||||
Evoque Eos | Edwards Lifesciences | TFV, TS | 28-F | Bovine pericardial valve secured by subannular anchors | MISCEND (NCT02718001) | X | ||||
AltaValve | 4C Medical | TA | 32-F | Valve secured within a supra-annular spherical cage | NCT03997305 | X | ||||
Clarity | Highlife Medical | TFV, TS | 39-F | 2-component device; valve implanted within a subannular ring | HighFLO (NCT04888247) | X | ||||
Cephea | Abbott Structural | TFV, TS | 38-F | Valve anchored by axial compression created by ventricular and atrial disks | NCT05061004 | X | ||||
Cardiovalve | Cardiovalve | TFV, TS | 28-F | Low-profile design featuring 3 scalloped bovine pericardial leaflets | AHEAD (NCT03339115) | X | ||||
Saturn | Innovheart | TA | Central valve component anchored in an annular ring | NCT04464876 | X | |||||
Innostay | Innovalve | TFV, TS | 32-F | Circumferential arm design seals annulus using a rotational maneuver during deployment | TWIST-EFS (NCT04919980) | X | ||||
Annuloplasty | Carillon | Cardiac Dimensions | CS | 9-F | Device with proximal and distal helical anchors that plicate mitral periannular tissue | EMPOWER (NCT03142152) | X | X | ||
ARTO | MVRx | CS | 12-F | Anchors implanted in the lateral wall via the CS and the septum are bridged to reduce the MV minor axis dimensions. | MAVERICK (NCT03311295) | X | ||||
Other | NeoChord | NeoChord | TA (DS1000) TFV, TS (NeXuS) |
28-F | Neochordae created using a device that features a helical papillary muscle anchor and a suture that grasps the MV leaflet. | ReChord (NCT02803957) (TA) |
X | X (TA) | ||
Half Moon | Half Moon | TFV, TS | 29-F | Improved native leaflet coaptation by filling the posterior aspect of the regurgitant orifice with an ePTFE-coated device implanted in a circular frame | NCT04343313 | X |
CE = Conformite Europeenne; CS = coronary sinus; EFS = early feasibility study; ePTFE = expanded polytetrafluoroethylene; FDA = Food and Drug Administration; mTEER = mitral transcatheter edge-to-edge repair; MV = mitral valve; TA = transapical; TFV = transfemoral vein; TMVR = transcatheter mitral valve replacement; TS = transseptal; other abbreviation as in Table 1.