• Ample Medical (Foster City, California), which manufactures endovascular medical devices for repairing heart valves, reported the first human implants of its PS3 System. The successful implants, performed at University Hospital (Caracas, Venezuela), mark the initiation of the clinical phase for the PS3 System. The PS3 System was implanted in two patients prior to open-heart surgery then removed during the surgical procedure. In both patients, the intended surgical intervention included repair of the mitral valve with an annuloplasty ring. The PS3 System is an investigational device for the percutaneous endovascular repair of congestive heart failure-related mitral valve regurgitation.

• Lumen Biomedical (Plymouth, Minnesota) said that it has received FDA clearance to market its first product in the U.S., the Xtract Aspiration Catheter. The new device is indicated for use in the removal of thrombi and soft emboli from vessels throughout the body. The Xtract, a single-use, 0.014” guidewire compatible, temporary intra-vascular extraction and aspiration catheter system can be used with other devices during vascular intervention procedures to restore normal blood flow after blockages created by clots within the vessels. The Xtract also will be part of the company's FiberNet Embolic Protection System, currently under clinical evaluation in the U.S.

• Stem Cell Innovations (Houston), a cell biology company that has developed technology capable of creating a broad range of human cells from its pluripotent stem cells, said that scientists at Johns Hopkins University (Baltimore) have engineered new, completed, fully working motor neuron circuits in paralyzed adult animals, according to a study published in the June 26 edition of Annals of Neurology. In a video released the same day, the Johns Hopkins team shows a previously paralyzed rat – following stem cell transplantation 12 weeks earlier – regain its ability to walk again. Stem Cell Innovations in April filed patent applications relating to the production of its own human motor neurons and progenitors. CEO Dr. James Kelly said, “The Johns Hopkins announcement is a spectacular study that reinforces the path we are taking at Stem Cell Innovations. We hope that our human motor neurons might prove to be as effective in eventual human trials.”

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