|FDA Approves Expanded Indication for Edwards Lifesciences' Transcatheter Valve; Abbott Receives Positive Opinion from CHMP|
|By Staff and Wire Reports|
|Friday, 19 October 2012 18:30|
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced it has received approval from the US FDA to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs). With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve. Previously, SAPIEN was approved in the U.S. only for the treatment of inoperable patients via the transfemoral approach.
"We are thankful to the multidisciplinary Heart Teams who worked diligently throughout The PARTNER Trial to bring new treatments to U.S. patients at high risk for surgical aortic valve replacement," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "It is extremely rewarding for us and our clinical partners to know that high-risk patients suffering from this often debilitating disease will now have access to this life-saving therapy."
About Transcatheter Aortic Valve Replacement (TAVR) In performing the TAVR procedure, the valve is crimped onto the catheter-based delivery system and inserted into the body in one of two ways: transfemorally or transapically. Once delivered to the site of the patient's diseased valve, the SAPIEN valve is expanded with a balloon and immediately functions in place of the patient's native aortic valve.
The Edwards SAPIEN valve is indicated for the treatment of patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a Heart Team, including an experienced cardiac surgeon and a cardiologist, and found to be inoperable or at high risk for traditional open heart surgery, and in whom existing co-morbidities would not preclude the expected benefit from the procedure. The previous FDA approval for the treatment of inoperable patients was granted on Nov. 2, 2011.
Abbott (NYSE: ABT) announced the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for HUMIRA® (adalimumab) for the treatment of pediatric patients aged six to 17 years with severely active Crohn's disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next several weeks. Upon final decision, HUMIRA will be the only biologic in the European Union (EU) for the treatment of pediatric CD offering at-home administration.
Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide(i,ii) CD most commonly involves the end of the small intestine and the beginning of the large intestine.(iii) In addition to symptoms such as chronic abdominal pain, weight loss and loose stools(i) pediatric CD can affect children in several ways, including potentially contributing to malnutrition, failure to grow and/or delayed puberty.(i,iv)
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centred on its proprietary anti-apoptosis therapeutic protein MANF, today announced that it has appointed Clinton O. Allen to its Advisory Board.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that it has received approval from the United States Food and Drug Administration (FDA) to treat high-risk aortic stenosis patients with the Edwards SAPIEN transcatheter aortic heart valve delivered both transfemorally (via the leg) and transapically (through the ribs).
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended September 30, 2012 of $69.2 million, or $0.58 per diluted share, compared to net income of $51.6 million, or $0.43 per diluted share, for the same period in 2011.
Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced they received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending approval of Amyvid (Florbetapir F 18) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive impairment.
Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that investigators will present data from over 80 studies that provide new information about the benefits of using Given Imaging's products to detect, monitor and measure a range of gastrointestinal conditions at the upcoming American College of Gastroenterology (ACG) 2012 Annual Meeting taking place October 19-24, 2012 in Las Vegas, and the 20th United European Gastroenterology Week taking place October 20-24, 2012 in Amsterdam, The Netherlands.