Abstract: A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.

Abstract: A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Abstract: A method for processing ECG records from multiple patients for clinician overreading includes identifying an unread group of current ECG records from multiple patients awaiting clinician overreading. Each ECG record in the ungroup includes at least a current ECG data, a current waveform measurement, a current interpretative statement, and a serial comparison statement. A set of prioritization rules is applied with a processor to prioritize the current ECG records in the unread group into a prioritized order for clinician overreading based on at least one of the current waveform measurements, the current interpretive statements, and the serial comparison statements. The current ECG records are then presented in the prioritized order for clinician overreading.

Abstract: A method for delivering a prosthetic valve to a patient's heart having a native valve with a plurality of valve leaflets includes providing a delivery device with a prosthetic valve, advancing the delivery device toward the native valve, and expanding a portion of the prosthetic valve to form a flanged region that is upstream of the valve leaflets. One or more tabs on the prosthetic valve are released so that they expand outward to a position that is transverse to the longitudinal axis of the prosthetic valve. The position of the prosthetic valve is adjusted relative to the valve leaflets and rapid pacing is applied to the patient's heart so that the valve leaflets move inward toward the prosthetic valve or the delivery device. The tabs are further released to allow the tabs to move into their final positions.

Abstract: A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.

Abstract: In one embodiment, an ECG monitoring system includes two or more electrodes configured to record cardiac potentials from a patient, at least one processor, and a rapid acquisition module executable on the at least one processor to: determine that an impedance of each electrode is less than an impedance threshold; record initial ECG lead data based on the cardiac potentials; determine that a noise level in each ECG lead of the initial ECG data is less than a noise threshold; start a recording timer once the noise level is below the noise threshold; record an ECG dataset while the noise level is maintained below the noise threshold until the recording timer reaches a predetermined test duration; store the ECG dataset and provide a completion alert.

Abstract: A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Abstract: In one embodiment, an ECG monitoring system includes two or more electrodes configured to record cardiac potentials from a patient, at least one processor, and a rapid acquisition module executable on the at least one processor to: determine that an impedance of each electrode is less than an impedance threshold; record initial ECG lead data based on the cardiac potentials; determine that a noise level in each ECG lead of the initial ECG data is less than a noise threshold; start a recording timer once the noise level is below the noise threshold; record an ECG dataset while the noise level is maintained below the noise threshold until the recording timer reaches a predetermined test duration; store the ECG dataset and provide a completion alert.

Abstract: A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.

Abstract: The hands-free dog leash system is an anchoring system that is adapted for use with a belt that is worn by an individual. The hands-free dog leash system is further adapted for use with a tether. The tether is attached to the hands-free dog leash system to anchor the tether to the belt. Tethers attached to the hands-free dog leash system remain with the belt and will not be separated from the individual. Tethers attached to the hands-free dog leash system more robustly handle unexpected forces that are delivered through the tether than hand carried tethers. The hands-free dog leash system comprises one or more tether units. Multiple tether units can be interconnected to form a larger single unit.

Abstract: A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Abstract: A device for loading a prosthesis onto a delivery system includes a first housing having a central bore. One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Abstract: Methods for the rapid retraction of trans-catheter heart valve delivery systems are provided. A rapid retraction trans-catheter heart valve delivery system comprises a catheter based delivery system. The delivery system has internal mechanisms that allow for the controlled deployment of a heart valve prosthesis, as well as mechanisms that allow for quickly closing the catheter once the heart valve prosthesis has been implanted. This rapid retraction ability allows for reduced procedural durations and thus reduced risk to the patient.

Abstract: In one embodiment, an ECG monitoring system includes two or more electrodes configured to record cardiac potentials from a patient, at least one processor, and a rapid acquisition module executable on the at least one processor to: determine that an impedance of each electrode is less than an impedance threshold; record initial ECG lead data based on the cardiac potentials; determine that a noise level in each ECG lead of the initial ECG data is less than a noise threshold; start a recording timer once the noise level is below the noise threshold; record an ECG dataset while the noise level is maintained below the noise threshold until the recording timer reaches a predetermined test duration; store the ECG dataset and provide a completion alert.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic valve comprises a self-expanding frame which includes a self-expanding atrial skirt that forms a flanged region, a self-expanding ventricular skirt, and a first self-expanding tab coupled with the ventricular skirt. A receptacle for receiving a valve leaflet is formed by the area bounded by an outer surface of the atrial skirt, an outer surface of the ventricular skirt, and an inner surface of the first tab. The receptacle has a window for receiving the valve leaflet that is defined by a gap between an edge of the flange and a tip of the first tab. The gap is maximized when the tip of the first tab is unconstrained and a base of the first tab is at least partially constrained. The gap is minimized when the tip of the first tab and its base are unconstrained.