|Covidien’s Embolic Receives FDA Clearance; Idera Announces FDA Authorization to Proceed with Phase 2 Clinical Trial of IMO-3100|
|By Staff and Wire Reports|
|Thursday, 01 December 2011 18:57|
Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has cleared SpiderFX® for the treatment of severely calcified lesions used in conjunction with plaque excision in arteries of the lower extremities. It is the only embolic protection device indicated for this treatment in the United States.
Covidien's SpiderFX is the only embolic protection device in the U.S. indicated for use in the lower extremities. (Photo: Business Wire)
Embolic protection devices are used to capture and remove debris that becomes dislodged during an interventional procedure. Embolic debris may block smaller vessels, resulting in procedural complications or poor patient outcomes. While the risk of complications associated with embolic debris exists during all types of interventional procedures, patients with complex conditions such as critical limb ischemia, single vessel runoff or complex lesions (such as calcium or thrombus) face even greater risk.
Covidien submitted the 510(k) to the FDA seeking clearance for use of the SpiderFX embolic protection device in lower extremity endovascular procedures, based on results from the DEFINITIVE" Ca++ clinical study. DEFINITIVE Ca++ enrolled 133 subjects from 17 investigational clinical sites. It demonstrated that plaque excision with Covidiens TurboHawk" device utilizing distal embolic protection with the SpiderFX can be used safely and effectively in patients who have severely calcified superficial femoral artery and popliteal artery lesions, including those with single vessel runoff.
The expanded indication of these devices offers interventionalists a safer option for dealing with severely calcified lesions. In complex cases, this technology shows promise of being a positive step forward for treating patients with peripheral arterial disease, said Daniel Clair, M.D., Chairman of the Department of Vascular Surgery at the Cleveland Clinic and Professor of Surgery, Cleveland Clinic Lerner College of Medicine. Dr. Clair does research consulting work with Covidien.
Idera Pharmaceuticals Inc (NASDAQ:IDRA) announced the receipt of verbal notification from the Food and Drug Administration (FDA) the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the Company in October 2011.
IMO-3100 is a dual antagonist of Toll-like receptor (TLR) 7 and TLR9 and is in clinical development as a potential therapy for autoimmune and inflammatory diseases.
AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, today announced that its agreement with OOO CardioNova ("CardioNova"), a Russian subsidiary of Maxwell Biotech Group ("Maxwell"), to license territorial development and commercialization rights for AtheroNova's AHRO-001 lead compound has been ratified by both companies.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.
Codexis, Inc. (Nasdaq: CDXS) today announced the company will participate in the Goldman Sachs Sixth Annual Clean Energy and Power Conference, to be held in New York, NY on December 8-9, 2011.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, in development for the treatment of B-cell malignancies has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) patients.
Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today provided an update on the status of the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.
Hadasit Bio-Holdings, Ltd. - (OTCBB: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by the Hadassah University Hospital, Israel's foremost medical research center, announced that three more of its portfolio companies have received grant approvals from the Israeli Office of the Chief Scientist (OCS) in the Ministry of Industry, Trade and Labor.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that it has entered into a multi-year lease for a 21,000 square-foot facility at One Kendall Square in Cambridge, MA.
Moog Inc. (NYSE: MOG.A) (NYSE: MOG.B) announced today that its Board of Directors has elected John Scannell to be Chief Executive Officer. Robert T. Brady, who has been Chairman and Chief Executive Officer, will continue in the role of Executive Chairman.
Neoprobe Corporation (NYSE Amex: NEOP) today announced that Dr. Mark Pykett, Neoprobe’s President and Chief Executive Officer will be participating in the following investor conferences over the coming weeks
Covidien’s Embolic Protection Device Receives FDA Clearance
Pfizer Inc. (NYSE:PFE) today announced that it has completed its previously announced acquisition of Ferrosan Consumer Health’s business, which includes dietary supplements and lifestyle products, from Altor 2003 Fund GP Limited.
Quidel Corporation (NASDAQ: QDEL), a leading provider of diagnostic testing solutions, announced today that it has received the CE Mark for its Sofia Strep A FIA for use with its Sofia Analyzer.
Santarus, Inc. (NASDAQ: SNTS) today announced that new data from a clinical study to assess the efficacy and safety of eight weeks of open-label treatment with the investigational drug UCERIS™ (budesonide) 9 mg Tablets in patients with mild or moderate active ulcerative colitis will be available in poster sessions on December 2–3, 2011 at the Crohn’s & Colitis Foundation’s Clinical & Research Conference, 2011 Advances in Inflammatory Bowel Diseases being held in Hollywood, Florida.
Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINK SHEETS:SLXCF) ("Stellar") and privately held Tribute Pharmaceuticals announced today that Stellar has acquired 100% of the outstanding shares of Tribute Pharmaceuticals Canada Ltd. and Tribute Pharma Canada Inc. (together herein referred to as "Tribute"), creating a premier North American specialty pharmaceutical company.
VIVUS, Inc. (NASDAQ: VVUS) today announced that Timothy Morris, chief financial officer, will present an overview of the company at the 2011 Deutsche Bank BioFEST Conference.