A proposal to improve the quality and reliability of automated external defibrillators (AEDs) has been issued by the U.S. Food and Drug Administration. Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is finalized. AEDs are medical tools that are portable and electronic… …read more
Source: FULL ARTICLE at Medical News Today
Tag Archives: PMA
FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators
By Larry Husten
Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. …read more
Source: FULL ARTICLE at Forbes Health
Cytori Provides Update in 510(k) Appeal Decision
By Business Wirevia The Motley Fool
Filed under: Investing
Cytori Provides Update in 510(k) Appeal Decision
SAN DIEGO–(BUSINESS WIRE)– Cytori Therapeutics (NAS: CYTX) today announced that the United States Court of Appeals for the District of Columbia Circuit has ruled on the Company’s conjoined appeals (case no. 11-1268).
The court upheld the FDA‘s (Food and Drug Administration) previous determination that Cytori’s cell processing devices were not substantially equivalent to the cited predicate devices. Cytori will continue to pursue its intended pathway to regulatory approval via the PMA (Premarket Approval) route, such as the active ATHENA clinical trial for refractory heart failure. Cytori received IDE (Investigational Device Exemption) in January 2012 required to initiate the ATHENA clinical trial.
“This decision reaffirms our primary regulatory pathway in the U.S.,” said Christopher J. Calhoun, Chief Executive Officer of Cytori. “Our priority remains unchanged, which is completion of clinical development of our Celution® System in refractory heart failure under the FDA‘s PMA clinical trial-based pathway for class 3 medical devices. Such a pathway provides the necessary data for approval, adoption, and reimbursement and will raise an additional barrier-to-entry for potential competitors who would be required to pursue the same PMA pathway. As a result, this decision further clarifies the standard-of-evidence required for the field.”
Cytori has been pursuing parallel pathways to market. One pathway has been to obtain therapeutic indications, such as those being pursued in our cardiac development. The other pathway has been to obtain clearance for laboratory equipment that would provide technology access to researchers, for which Cytori has achieved approval in Europe and Japan. Cytori appealed the decision based on a series of prior 510(k) clearances and a 2009 determination by the FDA, through a formal request for designation by the office of FDA‘s combination products, that Cytori’s cell processing technology would be regulated as a medical device and not a biologic. The appeal was related to the subsequent 2011 decision by the FDA to deny the 510(k) clearance for laboratory versions of our cell processing technology.
Regulatory Overview
The FDA regulates medical devices as class 1, 2, or 3. Typically, class 2 devices require a demonstration of substantial equivalence to a pre-existing device with limited or no clinical data. Class 3 devices are considered novel and more complex, thus require clinical data and/or clinical testing under the PMA pathway.
Cytori and the FDA agree that marketing approval for the Company’s Celution® System for use in …read more
Source: FULL ARTICLE at DailyFinance
Cerus Signs INTERCEPT Platelet Agreements With Two Key Blood Component Suppliers in Germany and Aust
By Business Wirevia The Motley Fool
Filed under: Investing
Cerus Signs INTERCEPT Platelet Agreements With Two Key Blood Component Suppliers in Germany and Austria
- TILAK, University Clinics, Regional Hospital Innsbruck (LKI), one of the largest hospitals in Austria, signs one year agreement for Cerus’ INTERCEPT platelet system.
- ZIT GmbH Hamburg (Zentralinstitut Hamburg), the largest in-house blood component supplier of the German Asklepios Group, signs four year agreement for the INTERCEPT Blood System for pathogen inactivation of platelet components.
CONCORD, Calif.–(BUSINESS WIRE)– Cerus Corporation (NAS: CERS) announced today that the TILAK, University Clinics, Regional Hospital Innsbruck (LKI) in Austria and ZIT GmbH Hamburg in Germany, signed one and four year purchase agreements, respectively, for the INTERCEPT Blood System for platelets.
LKI is one of the largest hospitals in Austria, with its Central Institute for Blood Transfusion supplying an estimated 6,000 platelet units annually to the federal state of Tyrol. LKI is the second facility in Austria to adopt INTERCEPT for platelets. Together with the General Hospital of Vienna (AKH), an estimated total of 12,000 platelet units, or 30% of the Austrian platelet market, could be treated with INTERCEPT. Implementation of the INTERCEPT platelet system at LKI is expected to start in March 2013.
ZIT Hamburg supplies roughly 10,000 platelet units annually and is the largest in-house blood component supplier to the Asklepios Group, one of the three largest operators of private hospitals in Germany. Implementation is expected to occur upon ZIT Hamburg’s receipt of regulatory approval from the Paul-Ehrlich-Institut to produce INTERCEPT-treated platelets.
“Considering the inherent limitations and increasing cost of the current testing strategies used for platelets, we believe the INTERCEPT Blood System for platelets offers a strong value proposition that combines patient safety with commercial benefits,” stated O. Schertges, CEO of the ZIT Hamburg.
“We believe the breadth of clinical and routine-use data for INTERCEPT platelets accumulated over the last 10 years may have positively influenced the decisions made by LKI and ZIT Hamburg,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “It is this clinical experience and hemovigilance data that led to FDA‘s recent agreement to allow Cerus to proceed with a modular PMA submission for INTERCEPT platelets without the need to conduct another prospective clinical trial.”
ABOUT CERUS
Cerus Corporation is a biomedical products …read more
Source: FULL ARTICLE at DailyFinance
Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy System for Coronary Artery Di
By Business Wirevia The Motley Fool
Filed under: Investing
Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy System for Coronary Artery Disease Treatment
Modular Application Includes ORBIT II Data that Surpassed the Trial’s Primary Endpoints
ST. PAUL, Minn.–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , announced today that it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its orbital atherectomy system, used to treat calcified coronary arteries.
The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI‘s technology produced clinical outcomes that exceeded the trial’s two primary safety and efficacy endpoints by a significant margin—within one of the most challenging patient populations.
“Coronary arterial calcium is a vastly underestimated problem in medicine today, and there is a pressing need for a solution,” said David L. Martin, president and CEO of Cardiovascular Systems. “The ORBIT II results we shared at ACC show that our orbital atherectomy technology may be a viable treatment option for calcified coronary arteries. We look forward to working with the FDA on a potential coronary indication for this most challenging, underserved patient population.”
The company completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study in history to evaluate this problematic subset of patients. At ACC, Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, presented data that showed a 30-day freedom from MACE (major adverse cardiac events) rate of 89.8 percent and procedural success of 89.1 percent (including in-hospital MACE).
According to estimates, moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. Moderate-to-severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and MACE. Coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.
The FDA agreed to a modular PMA process that allowed CSI to submit the first two modules covering preclinical data and manufacturing/quality systems, while still collecting, compiling and analyzing the clinical data. CSI has now …read more
Source: FULL ARTICLE at DailyFinance