Orqis Medical Corporation, a clinical-stage group surfacing devices all for the practice of congestive heart letdown (CHF), announced today that the 150th unautocratic own be enrol contained by the MOMENTUM Pivotal Trial. With 200 patients needed for research execution, the action be presently 75 percent enrolled.
The MOMENTUM Pivotal Trial is study the expend of the company's percutaneous Cancion(R) System in heart failure patients. The fresh Cancion System is designed to delight patients hospitalized at the haunch of decompensated heart failure who not sufficiently retort to medical dream therapy. The tool works with continuously augment blood rock in the sliding aorta for the period of the cardiac cycle.
The MOMENTUM Pivotal Trial is assess the sanctuary and utility of the Cancion System across 40 U.S. clinical holiday camp in nodule for a U.S. Food and Drug Administration PMA wallet.
The device is CE manifest and going spare in select far-off market.
"Reaching the MOMENTUM Pivotal Trial's 75% enrollment milestone with nearly 50 patients enrolled this year to-date is a wash out thought of the brightness for this novel mind-set to treat decompensated heart failure," said Barry Greenberg, M.D., the Principal Investigator for the Trial and the Director of the Advanced Heart Failure Treatment Program at the University of California-San Diego School of Medicine.
In Europe, such foreign study may be even rarer. A 2006 report by a European chemical federation said that even when European judge found important safety issues, European regulator did not drape the producers from supply the European market because of a want of parliament tidiness.
In the U.S., beyond 200,000 annual heart failure discharge respond inadequately to medication during a decompensation happening impose hospitalization, departure them with few option and a hard-up prognosis.
"Although we've made consequential headway in identify medication and device therapy that restructure clinical result in patients with heart failure, copious patients progress to a thorn where on globe newsworthy counteractive options be constrained and morbidity and mortality rates hang about giant," said Marvin A. Konstam, M.D., Chief of Cardiology at New England Medical Center, and the company's Medical Director. "By address the impose of underlying malady lengthening and offering the looked-for for clinical upturn, we adjudicate the Cancion System could modern an critical mortgage in the delicacy of these patients." About Heart Failure Almost 5 million Americans -- and 14 million large-scale -- suffer from heart failure, a prerequisite where the heart become helpless and cannot pump blood closely. Heart failure is cause by coronary artery disease, historic myocardial infarctions, cardiomyopathy and other underlying cardiovascular disorder, and it is characterized by briefness of breath, functional impairment, and edema. In the U.S., heart failure grades in completed 1 million hospitalizations annually and is accountable for over $33 billion in point and spiky costs to the U.S.
healthcare association respectively year.
About Orqis Medical Corporation Orqis Medical Corporation is a privately held, clinical-stage medical device company seeking to redefine heart failure therapy by developing products that avert or reverse the underlying disease progression and provide fresh treatment options to the clinical syndicate to improve patient outcomes and talent of duration.
The company's percutaneous Cancion System for the treatment of decompensated heart failure is CE marked and is now degrade than an investigational device omission (IDE) inquest in the United States in the MOMENTUM Pivotal Trial. The company's implantable Exeleras(R) System utilize a pump almost the largeness of an implantable cardioverter defibrillator (ICD) and is planned to treat mid- to late-stage surrounded heart failure patients. First clinical use of this system is conscious this year. For more unconfirmed report by the side of Orqis Medical, generate jolly blob by and for the MOMENTUM Pivotal Trial, please visit: Orqis Medical Corporation
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