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K2M Launches CASPIAN Spinal System To Address Cervico-Thoracic Pathologies
K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced the launch of the CASPIAN™ Spinal System. CASPIAN is an all-inclusive system for rigid posterior fixation addressing the high surgeon demand for treatment of complex cervico-thoracic spinal conditions.

NYT Editorial Urges Gov. Paterson To Sign Bill Prohibiting Shackling Of Female Prisoners During Labor
New York Gov. David Paterson (D) should sign a bill prohibiting the "barbaric and medically hazardous practice of shackling female prisoners during labor," a New York Times editorial states. Along with "further frightening these vulnerable women, the practice of chaining their legs, wrists and even their abdomens" during labor "makes treatment and delivery more difficult and places mother and child at greater risk of harm," according to the Times. It adds that five states have similar policies in place. The American College of Obstetricians and Gynecologists several years ago called for an end to shackling during labor, and the Federal Bureau of Prisons last fall "ended the routine use of restraints for women in labor and limited shackling to cases in which a woman presents a danger to herself, the baby or the staff," the editorial states.The New York measure, which is "[m]odeled on federal prison policy and laws in other states, … would prohibit women from being shackled while being taken to the hospital for a delivery," although an inmate "could be cuffed by one wrist in cases in which she presented a danger to herself, hospital staff or corrections workers," the editorial states. However, "it seems highly unlikely that a woman doubled over in labor pains would be able to attempt an escape or overcome corrections officers," it notes.The bill "has caused a debate about how many pregnant women are actually shackled in New York," but "recent interviews of female inmates by the Correctional Association of New York … sugges[t] that the practice may be more common than corrections officials know," the editorial continues. "In any case, the bill would put an end to it, by establishing clear guidelines that carry the authority of law," according to the editorial. It adds that Paterson "should make it clear whether he thinks the measure needs minor changes or clarifications." The editorial concludes, "Otherwise, he should sign the bill into law" and "bring New York into line" with the federal government and other states "that have wisely acted to protect pregnant inmates and their children during labor" (New York Times, 7/21).
News of the day
ERK1 And ERK2 Activities Are Key To Ovarian Functions And Fertility
Two enzymes called extracellular signal-regulated kinases (ERK1 and ERK2) are critical factors in a pathway that induces ovulation, maturation of the mammalian egg (oocyte) and other activities key to ovarian function and female fertility, said a group of researchers at Baylor College of Medicine (BCM) in a report that appears today in the journal Science.
Diagnostics

Lutonix, Inc. Announces First Patient Enrollments In Three Separate Clinical Trials

Lutonix, Inc., a privately held medical device start-up, announced that patient enrollment is underway for its three simultaneous first-in-human clinical trials. The three studies are designed to test whether the proprietary Lutonix Drug Coated Balloon (DCB) Catheter is safe and effective in the treatment of vascular narrowing. The PERVIDEO I Registry The PERVIDEO I Registry is investigating the Lutonix Drug Coated Balloon Catheter for the treatment of coronary bare metal stent in-stent restenosis (ISR). The study will assess various safety and clinical endpoints over a two year period. Dr. Laura Mauri, Associate Physician and Director of Biometrics at Brigham & Women"s Hospital in Boston, MA is serving as the Principal Investigator for the study along with Co-Principal Investigator Prof. Detlef Mathey of the Medical Center in Hamburg, Germany. The first patient was enrolled by Prof. Mathey. "It is very exciting to have the PERVIDEO I study underway," said Dr. Mauri. "The scientific evidence collected from this investigation will support the initiation of large global trials in the near future," she added. Prof. Mathey states, "I have been involved in DCB research for several years now and I believe this technology, if formulated correctly, shows great promise for treating many types of coronary diseases, including bare metal ISR." The LEVANT I Trial The LEVANT I Trial is a randomized study designed to test the safety and efficacy of the Lutonix Drug Coated Balloon Catheter in preventing restenosis in the femoropopliteal arteries. Scheduled clinical and safety visits will assess endpoints out to two years. Study Principal Investigator Prof. Dierk Scheinert, Director of Angiology at the Park-Krankenhaus in Leipzig, Germany states, "The initiation of the LEVANT I study is a major milestone and I am honored to lead such an outstanding group of physician investigators." Prof. Scheinert adds, "The optimal intervention treatment strategy for this population has yet to be discovered, and the DCB technology may mark the next major advancement in peripheral interventions." The first patient was enrolled by Prof. Stephan Duda of the Jewish Hospital in Berlin, Germany. The Lutonix De Novo Pilot Study The Lutonix De Novo study will assess the interaction between bare metal stents and the Lutonix Drug Coated Balloon Catheter. Safety and clinical outcome data will be collected over two years. Prof. Patrick Serruys, Chief of Cardiology at Erasmus Medical Center in Rotterdam, the Netherlands is serving as study Principal Investigator. The first patient was enrolled by Dr. Jacques Koolen at Catharina Hospital in Eindhoven, the Netherlands. President & CEO Dr. Dennis Wahr added, "Lutonix is committed to the principle of clinical excellence and dedicated to substantially improving long term patient outcomes. Through close collaboration with global thought leaders and experienced CROs, we have been able initiate a clinical program designed to provide objective evidence that our DCB formulation is clinically effective." About Restenosis Restenosis is the re-narrowing of an artery experienced by some patients following angioplasty, atherectomy, or stenting. Restenosis is caused by an overgrowth of tissue inside the artery wall at the original treatment site. Restenosis is typically experienced by some patients within the first 6 months of treatment, which most often results in re-intervention or surgery. About Lutonix, Inc. Lutonix, Inc., co-Founded in July 2007 by Dennis Wahr, M.D. and Lixiao Wang PhD, is focused on the rapid development and commercialization of the safest and most efficacious drug coated balloon for the treatment of vascular disease in the coronary and peripheral arteries. Lutonix"s drug coated balloon technology is anticipated to enhance and broaden the therapeutic options for patients with vascular disease who may not be ideal candidates for conventional therapies such as balloon angioplasty and stents and for those who are contraindicated for those treatments. Lutonix is a venture-backed medical device start-up based in Minneapolis, MN. Current investors include: Delphi Ventures, Rivervest Ventures, US Venture Partners, and Versant Ventures. Lutonix, Inc


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