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NAMSR News: FDA approves donor lung preservation device

The U.S. Food and Drug Administration has approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs.

 
PRLog - Aug. 14, 2014 - ARLINGTON, Va. -- The U.S. Food and Drug Administration has approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ's function to determine whether the lung is viable for transplantation.

Lung transplantation is a primary option in the care of patients with end-stage chronic lung diseases, such as chronic obstructive pulmonary disease, cystic fibrosis and idiopathic pulmonary fibrosis. Approximately one in five donated lungs meets the standard criteria for a donor lung and is transplanted into a recipient. In 2012, 1,754 lung transplants were performed in the United States and at the end of that year, 1,616 potential recipients remained on the waiting list.

"This innovative device addresses a critical public health need," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "With this approval, there may be more lungs available for transplant, which could allow more people with end stage lung disease who have exhausted all other treatment options to be able to receive a lung transplant."

If additional time is needed to determine if a donated lung meets the standard criteria for lung transplantation, the XPS can be used to warm the donor lungs to near normal body temperature and continuously flush the lung tissue with a sterile fluid solution, called STEEN Solution, which preserves the lungs and removes waste products. The XPS also ventilates the lungs, which oxygenates the cells and makes it possible for the transplant team to examine the lungs' airways with a bronchoscope. Donor lungs can stay in the machine for up to four hours; during this time the transplant team can examine the lungs and evaluate their function. If after further evaluation the lungs meet certain functionality criteria, and pass the transplant surgeon examination, they are transplanted into a recipient.

The XPS received a Humanitarian Use Device (HUD) designation and was reviewed through the Humanitarian Device Exemption (HDE) pathway. A HUD is a device which treats or diagnoses a disease or condition affecting fewer than 4,000 individuals in the United States per year. In order to receive this type of approval, a company must demonstrate, among other things, safety and probable benefit, i.e., that the device will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit of the device outweighs the risk of illness or injury. In addition there can be no legally-marketed comparable devices, other than another HDE, available to treat or diagnose the disease or condition.

The FDA's review of the XPS included two clinical trials supporting the safety and probable benefit of the device. Both trials compared outcomes of lung transplant patients who received non-ideal donor lungs preserved using ex vivo lung perfusion with STEEN Solution to lung transplant patients who received ideal donor lungs that were preserved using conventional cold storage techniques. Both trials showed that recipients of the ideal and non-ideal lungs had similar survival rates up to 12 months after transplant and similar rates of organ rejection. As a condition of approval, the manufacturer will conduct a post-approval study of the long-term effects of the device and adverse events.

The XVIVO Perfusion System with STEEN Solution is manufactured by XVIVO Perfusion, Inc., of Englewood, Colorado.

CANDIDATES WHO WANT TO BREAK INTO MEDICAL SALES:

RMSR® Medical Sales Certification offered by the National Association of Medical Sales Representatives is designed for entry level medical device sales reps. The course covers a wide array of topics pertaining to industry knowledge that candidates need to acquire before applying to medical sales positions.

The course and training helps to develop the industry skills, maximizing the candidates’ potential and goals, as well as making them feel valued and stimulated in their role when communicating with members of the medical community. By an applicant acquiring medical sales training and a RMSR Certification, it puts him/her in a position of strength and qualifies them for medical sales jobs. Medical knowledge is key in this industry and when communicating with doctors, surgeons, and nurses etc.

It is extremely important for representatives to use key terminology pertaining to the medical product he/she will be promoting. The only way to succeed in this industry is to garner actual sales. Doctors and Surgeons will not acknowledge a Sales Rep who is not proficient in essential medical terminology, knowledgeable of medical devices/equipment and the anatomy. For those lacking a solid sales background the RMSR course covers knowledge of medical selling techniques and regulation such as Effective Territory Management, Effective Networking, Medical Sales Ethical & Regulatory Guidelines and more.

The National Association of Medical Sales Representative™ (NAMSR) is the largest professional association in the world for Medical Sales Representatives. Through our numerous members, the NAMSR™ provides accredited training, continuing education, information about the industry, up-to-date news, programs to assist medical sales reps in their work, training programs to assist candidates who want to break into the industry and initiatives to improve communication with the medical sales field.

For more information on the NAMSR or the RMSR certification visit www.medicalsalescareer.com or call 800-313-9198


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