|Spectranetics Announces FDA Clearance for Mechanical Lead Extraction Devices; Celladon Receives Breakthrough Therapy Designation for MYDICAR|
|By Staff and Wire Reports|
|Thursday, 10 April 2014 20:01|
The Spectranetics Corporation (Nasdaq: SPNC) announced FDA clearance of two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads. Each incorporates innovative designs for mechanical extraction aimed at providing total lead management solutions.
The TightRail™ rotating mechanical sheath platform combines unprecedented shaft flexibility and column strength to help physicians safely navigate the vasculature during cardiac lead extraction procedures. An advanced forward-facing dilating blade remains shielded until activated. The tip feature rotates in both directions for efficient dilation. The physician controls when the blade is exposed, for procedural safety.
The SightRail™ manual dilator sheath platform features visual indicators that show bevel orientation and tip alignment, supplementing fluoroscopy as a means to determine position and orientation. A longer inner sheath gives physicians improved ability to grip and manipulate the device, especially when advancing and rotating. The SightRail sheath set has also received CE mark approval for use in Europe.
These new platforms represent Spectranetics' entry into the mechanical extraction device market and complement the laser-based technology that established the company's leading position in lead extraction.
Charles Love, M.D., Professor of Medicine and Director of Cardiac Rhythm Device Services at New York University Langone Medical Center, has been performing extractions since 1988. "In my experience, removing cardiac leads requires skill, patience and the right tools," said Love.
"Identifying bevel orientation can be challenging with fluoroscopy alone, so the visual direction offered by the SightRail sheath helps ensure proper sheath positioning and tip orientation when working in the superior vena cava (SVC)."
Love pointed out the utility of the TightRail mechanical sheath in aligning with the curves and bends characteristic of the SVC. "Leads rarely take a straight course through the vasculature," he said. "Having a flexible sheath that follows the curvature of the lead and maintains alignment with the lead is critical to successful extraction."
Spectranetics CEO Scott Drake sees the next-generation mechanical extraction devices as a welcome addition to the company's portfolio of lead extraction solutions. "Physicians consistently emphasize the need for the right tool at the right time for lead management. By providing a broader range of clinical solutions, our goal is to continue to enable safe, predictable outcomes in lead management," said Drake. "Our confidence in the long-term strength of this business continues to be driven by the launch of our mechanical tools portfolio and increasing contribution from our sales force expansion."
There are over seven million implanted cardiac devices globally. Each year, about 750,000 additional patients are implanted with these devices worldwide, translating to 1.5 million leads. It is estimated that in 2014, roughly 400,000 patients will meet indications for a lead extraction procedure.
Celladon Corporation (Nasdaq: CLDN), a clinical-stage biotechnology company developing novel therapies for patients with heart failure and other diseases characterized by SERCA enzyme deficiencies, today announced that its lead product candidate, MYDICAR®, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and where preliminary clinical evidence suggests it provides a substantial improvement over existing therapies. Celladon is developing MYDICAR as a novel, first-in-class therapy for patients with chronic heart failure due to systolic dysfunction. MYDICAR uses genetic enzyme replacement therapy to correct the deficiency in the enzyme SERCA2a, which is an enzyme that becomes deficient in heart failure patients and results in inadequate pumping of the heart. Celladon has developed a companion diagnostic to identify the patients who are AAV1 NAb negative and therefore eligible for MYDICAR treatment.
"We are looking forward to working with the senior staff at the FDA to determine the most expeditious path to bring MYDICAR to patients with advanced heart failure. This breakthrough therapy designation validates MYDICAR's unique characteristics and clinical data to date and underscores the urgent need for new treatments for heart failure," said Krisztina Zsebo, Ph.D., president and CEO of Celladon. "MYDICAR has the potential to provide transformative disease-modifying effects with long-term benefits in heart failure patients with a single administration. Our goal is to bring MYDICAR to market as quickly as possible in the United States, where we estimate approximately 350,000 heart failure patients with currently limited remaining treatment options could be eligible for therapy."
Celladon is currently evaluating MYDICAR in the Phase 2b CUPID 2 trial to determine its efficacy in reducing the frequency of and/or delaying heart failure-related hospitalizations. This randomized, double-blind, placebo-controlled, multinational trial is evaluating a single intracoronary infusion of MYDICAR versus placebo added to a maximal, optimized heart failure regimen in patients with NYHA class III or IV symptoms of chronic heart failure due to systolic dysfunction. Patient enrollment has been completed and 250 patients have been randomized in this trial. The Company expects to report results in April 2015.
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Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company developing novel therapies for patients with heart failure and other diseases characterized by SERCA enzyme deficiencies, today announced that its lead product candidate, MYDICAR®, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing hospitalizations for heart failure in NYHA class III or IV chronic heart failure patients who are NAb negative.
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Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that Dr. David M. Goldenberg, Founder and Chairman of the Board, and Cynthia L. Sullivan, President and Chief Executive Officer, will ring the Opening Bell at the NASDAQ MarketSite in Times Square, New York City, on Wednesday, April 23, 2014, in honor of the Company's 30-year uninterrupted listing on the NASDAQ Stock Market.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 23 new employees.
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The Spectranetics Corporation (Nasdaq:SPNC) today announced FDA clearance of two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads.
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