Feb 28 2011
Hotspur Technologies announced today that Dr. Thomas DiBartholomeo of Fairfield, CT, performed the first clinical use of its Keeper™ Embolectomy Catheter. The Keeper Catheter enables physicians to clear clot formation within arteries, while also incorporating the capability of injecting physician-specified fluids directly through the balloon catheter.
The Keeper Catheter combines a compliant embolectomy balloon with its proprietary VisioValve™ technology. This unique valve, located at the distal end of the device, allows the physician to inject fluids such as contrast or thrombolytics directly to the intended location of visualization or treatment. By combining these two frequently used tasks into one device, the Keeper Catheter allows a physician to potentially maintain guidewire position for an entire case.
Dr. DiBartholomeo used the device during multiple dialysis access procedures where the removal of clot was needed after vessel blockages began to limit necessary blood flow. The embolectomy balloon, which is compatible with vessels between 4mm and 15mm, was inflated and retracted to displace thrombus. Then, without needing to remove the balloon catheter or the guidewire, the VisioValve was opened and contrast injected to visualize device placement and to confirm successful clot displacement.
After utilizing the device, Dr. DiBartholomeo remarked, "This device deployment was highly successful. By being able to visualize the effectiveness of the clot removal without removing the balloon or the guidewire, the Keeper Catheter will be an effective tool in my dialysis access procedures. Moving forward, this device will play a key role in my procedures that require embolectomy."
The Keeper Catheter is one of Hotspur's first three commercially available products, all of which are based upon the VisioValve™ technology. This unique valve enables physicians to complete two frequently needed tasks with one balloon catheter. This multi-functionality may allow physicians to complete cases in a more time-efficient and cost-effective fashion.
Hotspur President & CEO Gwen Watanabe commented that "the successful introduction of the Keeper Catheter into the marketplace shows Hotspur's focus on effectively delivering solutions that help potentially reduce case complexity while being responsive to physicians' changing needs. We look forward to continue innovating throughout 2011 and beyond."
In addition to the Keeper Catheter, the company also has two additional products that have received 510(k) clearance from the U.S. Food & Drug Administration and are now commercially available. The GPSCath™ Balloon Dilation Catheter pairs a high-pressure angioplasty balloon with the VisioValve feature and is indicated for use within peripheral vessels, native fistulae, and dialysis access grafts. The IQCath™ Balloon Dilatation Catheter combines high-pressure angioplasty with an embolectomy coil and the VisioValve feature as is intended for use within synthetic dialysis grafts.
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