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April 7, 2008
POWRsyringe Injector wins Medical Device Design Excellence Award (MDEA)
Park City, Utah, Pinyons Medical Technology, Inc. announced it won a prestigious Medical Device Design Excellence Award (MDEA) for the POWRsyringe Injector.
The POWRsyringe Injector was named as one of the finalists in the Medical Device Design Excellence Award's General Hospital Devices and Therapeutics product category. The annual award recognizes global medical device companies and engineering teams for innovation and contributions to patient care. The award jury consists of independent third-party physicians, biomedical engineering professors, and practicing engineers.
Pinyons design team included contributions from Globe Med Tech (Houston, TX), Integrated Bioscience (Harrisburg, PA), and West Pharmaceutical (Montgomery, PA).
Using Pinyons intellectual property, Globe Med Tech (www.globemedtech.com) contributed to final design activities, new product features, and design for manufacturing activities to fulfill Pinyons product specifications and design inputs. Globe also delivered speed and accuracy in molding multiple versions of the POWRsyringe to confirm design outputs and product testing effectiveness.
Pinyons POWRsyringe devices molded and assembled in Globe's facilities also passed ISO 10993 biocompatibility and ISO 7886 syringe testing requirements. The multi-national Globe team is a product developer and contract manufacturer specializing in design and molding services for a variety of medical devices.
The combined Integrated Bioscience (www.ibiosci.com) and West Pharmaceutical (www.medtech-grp.com) team performed early product development and basic design activities. The two companies took Pinyons early concepts to create the POWRsyringe's base design allowing Pinyons to produce functional high-pressure prototypes for proof of principle testing and voice of customer activities with interventional cardiologists, interventional radiologists, and surgeons.
Gold and Silver Medical Device Design Excellence awards will be presented on June 4, 2008 at the annual Medical Device Design Industry meeting in New York City, NY.
November 14, 2007
Cost-Effective Spinal Discography Device Receives FDA Clearance: Pinyons Medical Technology’s PowrSyringe Expands with New Spine Indication
Park City, Utah, Pinyons Medical Technology, Inc. announced it received U.S. Food and Drug Administration (FDA) clearance to market the POWRsyringe Monitor™ for use in discography procedures.
Discography is a diagnostic tool to physiologically determine if a diseased, herniated, or abnormal vertebral disc in the spine is causing discogenic back pain prior to treatment. The POWRsyringe Monitor™ is a one-piece disposable hand-held medical device to deliver ergonomic and mechanical advantages to a high-pressure syringe for use in diagnostic discography.
The POWRsyringe Monitor™ is similar to the previously FDA cleared POWRsyringe Injector™ with integrated crossing handles that advance the plunger into the barrel when the handles are squeezed by a clinician. Many clinicians currently use high-cost, customized two-handed angioplasty balloon inflation devices to deliver and monitor pressure during discography procedures. These two-handed devices typically use a screw-auger type plunger to generate pressure and do not provide the clinician with tactile feedback for the injection.
With the POWRsyringe Monitor™, the clinician can control pressure with one-hand allowing their second hand to control catheters, needles, imaging, or other devices with tactile feel for the injection. “The POWRsyringe Monitor™ is a simple single-handed and cost-effective device that may be used for discography,” said Shawn Fojtik, Pinyons Chief Executive Officer. “Single-handed pressure delivery during discography with tactile feedback can be an important safety advantage and help improve patient care.”
October 10, 2007
FDA Clears Hand-Held Disposable Injector for Angiographic Imaging
Park City, Utah, October 10, 2007 - Pinyons Medical Technology, Inc. announced it received U.S. Food and Drug Administration clearance to market the POWRsyringe Injector™.
The POWRsyringe Injector is a disposable hand-held device that adds ergonomic and mechanical advantages to inject and aspirate fluids including use in angiography. The Injector’s crossing handles hinge to the syringe barrel and plunger to advance the plunger into the barrel when the handles are squeezed.
"The POWRsyringe Injector may improve image quality and reduce the amount of contrast media used per patient when compared to traditional control syringes used in angiography,” said Bruce Murphy, M.D., Ph.D., F.A.C.C., Medical Director, Arkansas Heart Hospital, and President, Little Rock Cardiology Clinic. “The device is simple and can be used without any new capital equipment.” “The PowrSyringe bridges the gap between syringes and electronic power injectors,” said Shawn Fojtik, Pinyons Chief Executive Officer. “POWRsyringe should deliver the ease-of-use, cost-effective, and tactile feedback characteristics of a syringe, plus the faster injection speed and image quality benefits of electronic power injectors. Improving global patient care and reducing costs is our company goal.”
May 9, 2006
Patent Awarded
Pinyons Medical Systems, Inc. Park City, Utah USA announced that a core licensed patent application was issued as a patent today with 19 claims from the United States Patent and Trademark Office on the POWRsyringe. Pinyons has the license to additional POWRsyringe continuations in part and other patent applications on file.
The POWRsyringe design adds ergonomic advantages to a control syringe with product applications in cardiac catheterization, interventional radiology, vascular surgery, spine, ear nose and throat, and general hospital use. The POWRsyringe is not for sale at this time.
Visit Pinyons Medical Technology, Inc. at www.pinyonsmedical.com or by e-mail at info@pinyonsmedical.com.
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