Abstract: An apparatus includes a catheter shaft extending from a proximal end to a distal tip. The apparatus includes a distal balloon positioned on a distal segment of the catheter shaft proximal to the distal tip. The distal balloon is coated with a Natural Vascular Scaffolding (NVS) treatment. The NVS treatment is configured to enhance maturation of an arteriovenous fistula.

Abstract: Apparatus and methods are provided for treating patients exhibiting symptoms of hypertension, isolated systolic hypertension, heart failure with preserved ejection fraction, May-Thuner Syndrome or dyspnea by diagnosing and reducing narrowing of a patient's iliac vein caused by extrinsic localized compression using a stent having circumferential differential radial stiffness and delivery catheter for aligning and deploying such stents.

Abstract: Distal protection devices (“DPDs”) and methods of use thereof for capturing and removing vascular debris are provided. The DPD may include a catheter having a distal region sized and shaped to be advanced in a target vessel of the patient. The distal region of the catheter may include a filter basket and fibrous filter disposed thereon, the fibrous filter upstream of the filter basket. The fibrous filter and the filter basket may both transition between a collapsed delivery state and an expanded deployed state. For example, the fibrous filter may be made of a frame coupled to a plurality of fibers, and may exhibit a helical shape in its expanded state such that the plurality of fibers capture and store vascular debris within the blood vessel. The filter basket may capture any vascular debris not captured by the fibrous filter, and may be collapsed and removed from the patient while retaining the vascular debris.

Abstract: Apparatus and methods are provided for treating patients exhibiting symptoms of hypertension, isolated systolic hypertension, heart failure with preserved ejection fraction, May-Thuner Syndrome or dyspnea by diagnosing and reducing narrowing of a patient's iliac vein caused by extrinsic localized compression using a stent having circumferential differential radial stiffness and delivery catheter for aligning and deploying such stents.

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, a lumen extending there between, and a plurality of through-wall apertures distributed along the distal region, the plurality of through-wall apertures in fluid communication with the proximal end and the lumen, and an expandable member disposed in the distal region, the expandable member configured to transition between a collapsed state and an expanded state. Methods of using the inventive biologics delivery device also are provided to achieve substantially uniform distribution of the biologic into a subintimal space.

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen; an expandable member disposed in the distal region, the expandable member configured to support a subintimal space in an occluded blood vessel of a patient, and to transition between a collapsed state and an expanded state; and a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, and into tissue surrounding the occluded blood vessel, wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel. Methods of using the inventive biologics delivery device also are provided to deposit the biologic from a subintimal space to tissue surrounding the occluded blood vessel.

Abstract: Bone marrow harvesting devices and methods of use for harvesting bone marrow from a biological source of bone marrow are provided that promote ease of use, and reduce patient pain and potential trauma to harvested bone marrow, wherein an exemplary bone marrow harvesting device includes an elongated shaft comprising a distal region, a proximal region, and a lumen extending therebetween, the distal region comprising a plurality of through-wall apertures in fluid communication with the lumen; and an expandable member disposed along the distal region thereof and configured to transition between a collapsed state and an expanded state for vibrating to disrupt the bone marrow. Methods of using the inventive bone marrow harvesting device to provide more efficient bone marrow disruption, improve the efficiency of bone marrow aspiration, and increase the quantity of bone marrow harvested in a single procedure are also provided.

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen; an expandable member disposed in the distal region, the expandable member configured to support a subintimal space in an occluded blood vessel of a patient, and to transition between a collapsed state and an expanded state; and a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, and into tissue surrounding the occluded blood vessel, wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel. Methods of using the inventive biologics delivery device also are provided to deposit the biologic from a subintimal space to tissue surrounding the occluded blood vessel.

Abstract: Bone marrow harvesting devices and methods of use for harvesting bone marrow from a biological source of bone marrow are provided that promote ease of use, and reduce patient pain and potential trauma to harvested bone marrow, wherein an exemplary bone marrow harvesting device includes an elongated shaft comprising a distal region, a proximal region, and a lumen extending therebetween, the distal region comprising a plurality of through-wall apertures in fluid communication with the lumen; and an expandable member disposed along the distal region thereof and configured to transition between a collapsed state and an expanded state for vibrating to disrupt the bone marrow. Methods of using the inventive bone marrow harvesting device to provide more efficient bone marrow disruption, improve the efficiency of bone marrow aspiration, and increase the quantity of bone marrow harvested in a single procedure are also provided.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter includes an elongated catheter shaft having a proximal end and a distal region, a first inflation lumen and a second inflation lumen extending from the proximal end to the distal region; a fluid impermeable balloon affixed to the distal region; an intermediate balloon affixed to the distal region to envelop the fluid impermeable balloon, the intermediate balloon having a first multiplicity of through-wall apertures; and an outer balloon affixed to the distal region to envelop the intermediate balloon, the exterior surface of the outer balloon comprising a coating of an agent; wherein the first inflation lumen is coupled to a first space enclosed by the fluid impermeable balloon, the second inflation lumen is coupled to a second space defined by the fluid impermeable balloon and the intermediate balloon, wherein the fluid impermeable balloon is configured to contact and expand the intermediate balloon against the outer balloon, and to e

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, a lumen extending there between, and a plurality of through-wall apertures distributed along the distal region, the plurality of through-wall apertures in fluid communication with the proximal end and the lumen, and an expandable member disposed in the distal region, the expandable member configured to transition between a collapsed state and an expanded state. Methods of using the inventive biologics delivery device also are provided to achieve substantially uniform distribution of the biologic into a subintimal space.

Abstract: A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen; an expandable member disposed in the distal region, the expandable member configured to support a subintimal space in an occluded blood vessel of a patient, and to transition between a collapsed state and an expanded state; and a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, and into tissue surrounding the occluded blood vessel, wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel. Methods of using the inventive biologics delivery device also are provided to deposit the biologic from a subintimal space to tissue surrounding the occluded blood vessel.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.