Abstract: A portable, wearable, cooling system for the avoidance and management of hyperthermia, and more particularly a self-contained cooling system that can be integrated into a garment. In one embodiment, the system comprises a removable cartridge having a cooling fluid therein, attached via tubing to a motorized pump driven by a power pack, such that the pump drives water from the cartridge through a circuit of tubes into a bladder that provides a cooling effect to the wearer. In another embodiment, the bladder is not a removable piece but is an integrated portion of the garment, formed by creating a lumen in between two layers of bonded material. The lumen is connected at both its ends to the tubing that mns to the cartridge and pump. Cooling fluid is pumped through the lumen and thereby cools the wearer due to the proximity to the wearer's skin.

Abstract: This disclosure is directed to methods of treating a subject with a fibrotic or fibroproliferative disease, comprising administering to the subject a composition comprising an effective amount of an anti-fibrosis agent, e.g., a CXCR4 and/or CXCR7 binding agent, such as CXCL12.

Abstract: A device for characterizing a luminal dimension, such as the aortic annulus, has also been developed. These include a balloon or basket with sensing and transmitting elements for assessing two or three dimensional shape of lumens using a guide wire and catheter. Sheath introducer devices were developed for percutaneous delivery of bioprosthetic valves during various percutaneous procedures, such as TAVI. A marker needle dispenser for pre-marking anatomical features that are either desirable to target or desirable to avoid has been developed. The needle contains a central passage or lumen for loading marker and spacer material. These are characterized by specific spacing, color, shape or diagnostic imaging criteria to facilitate passage through and placement within the vasculature. Hemostatic stents or balloons are used to prevent bleeding and facilitate closure at sites for entry of catheters or introducer sheaths into luminal structures, especially for procedures such as TAVI through the subclavian artery.

Abstract: Compositions, articles, and methods for treating and imaging vulnerable plaque and other inflamed regions in a patient rely on delivery of a conversion electron emitting source (CEES) to a body location. The CEES may be delivered by coupling to a substance which preferentially binds to vulnerable plaque or other inflammatory marker. Alternatively, the CEES can be delivered on a catheter, scaffold, or other device.

Abstract: Compositions, articles, and methods for treating and imaging vulnerable plaque and other inflamed regions in a patient rely on delivery of a conversion electron emitting source (CEES) to a body location. The CEES may be delivered by coupling to a substance which preferentially binds to vulnerable plaque or other inflammatory marker. Alternatively, the CEES can be delivered on a catheter, scaffold, or other device.

Abstract: A polymeric matrix for delivery of an HMG CoA reductase inhibitor such as a statin to tissue such as cardiac tissue in need thereof for the treatment or prevention of a disease or defect such as atrial fibrillation has been developed. In the preferred embodiment, a statin is delivered by means of a patch sutured to cardiac tissue at the time of cardiothoracic surgery. In the most preferred embodiment, the patch is a biodegradable material providing controlled or sustained release over a prolonged period of time, such as a week. Suitable materials include extracellular matrix, or other biodegradable hydrogels or polymeric materials providing sustained or controlled release of statin at the site of application.

Abstract: Methods, systems, and apparatus, for data management and access for drug and procedural testing. In one aspect, a method includes receiving dynamic trial data for an ongoing trial from a trial site, associating the dynamic trial data with a corresponding ongoing trial, storing the dynamic trial data for the ongoing trial in a data store, receiving a request to access the trial data for an ongoing trial and receiving sponsor credentials associated with the request, the sponsor credentials identifying a sponsor that provided the request, determining that the sponsor identified by the request is the sponsor of the ongoing trial for which the access to the trial data is requested, and in response to the determination, providing access to the trial data in response to the request, the access to the trial data including access to the dynamic trial data for the ongoing trial.

Abstract: Compositions, articles, and methods for treating and imaging vulnerable plaque and other inflamed regions in a patient rely on delivery of a conversion electron emitting source (CEES) to a body location. The CEES may be delivered by coupling to a substance which preferentially binds to vulnerable plaque or other inflammatory marker. Alternatively, the CEES can be delivered on a catheter, scaffold, or other device.

Abstract: Compositions, articles, and methods for treating and imaging vulnerable plaque and other inflamed regions in a patient rely on delivery of a conversion electron emitting source (CEES) to a body location. The CEES may be delivered by coupling to a substance which preferentially binds to vulnerable plaque or other inflammatory marker. Alternatively, the CEES can be delivered on a catheter, scaffold, or other device.

Abstract: Compositions, articles, and methods for treating and imaging vulnerable plaque and other inflamed regions in a patient rely on delivery of a conversion electron emitting source (CEES) to a body location. The CEES may be delivered by coupling to a substance which preferentially binds to vulnerable plaque or other inflammatory marker. Alternatively, the CEES can be delivered on a catheter, scaffold, or other device.

Abstract: This invention provides methods of forming new blood vessels in diseased or damaged tissue in a subject, methods of increasing blood flow to diseased or damaged tissue in a subject, and methods of increasing angiogenesis in diseased tissue in a subject, which methods comprise: a) isolating autologous bone marrow-mononuclear cells from the subject; and b) transplanting locally into the diseased or damaged tissue an effective amount of the autologous bone-marrow mononuclear cells, thereby forming new blood vessels in the diseased or damaged tissue. The new blood vessels may be capillaries or collateral vessels in ischemic tissue or any site of angiogenesis. Also provided are methods of treating tissue in disease or injury by local transplantation with an effective amount of the autologous bone marrow-mononuclear cells so as to induce vascularization in such diseased tissue.