Hotspur Technologies announced that Guy Mayeda, interventional cardiologist at Good Samaritan Hospital in Los Angeles, California, USA, performed the first commercial deployment of its IQCath Balloon Dilatation Catheter. This new device enables, for the first time, performance of three complex vascular procedures with one single catheter, potentially reducing procedure time and expense for both patients and medical professionals.
“The IQCath brings much needed efficiency and innovation to dialysis graft revascularisation procedures. The ability to perform balloon angioplasty, embolectomy, local drug delivery, and angiography with a single device should shorten procedure times, as well as reduce radiation exposure to both the operator and patients,” said Mayeda.
The IQCath is a three-in-one device that allows physicians to perform high-pressure angioplasty, inject fluids such as contrast, and perform embolectomy while maintaining guidewire position.
During this procedure, Mayeda brought the 5mm balloon to its RBP of 16 atmospheres ten times and performed five intermittent contrast injections while utilising the same catheter. In the past, in these types of medical procedures, physicians typically have had to use multiple catheters to open the blood vessels, which can be time-consuming and expensive. Hotspur’s products enable insertion of only one catheter for the entire procedure.
The IQCath is one of Hotspur’s first three devices that have received 510(k) clearance from the FDA. These three new Hotspur devices are focused on solving some of the key challenges associated with restoring blood flow to blocked or low flow dialysis access grafts and fistulaes and peripheral vessels.
“We have heard from physicians that they need devices that are purpose-designed for the many peripheral access procedures they perform regularly, rather than having to repurpose a variety of legacy devices designed for other procedures,” said Gwen Watanabe, president and CEO of Hotspur. “We are committed to responding to this need and bringing high quality and efficient
devices to a very broad and currently underserved market.”
Watanabe indicated that, based on the company’s analysis, there are as many of 800,000 procedures performed annually that could benefit from this multi-purpose approach to catheter design for the peripheral access market.
In addition to the IQCath, Hotspur has also gained 510(k) clearance for two additional innovative balloon technologies. The GPSCath Balloon Dilatation Catheter follows the lead of the IQCath as a specialty two-in-one device that allows the physician to conduct angioplasty and inject fluid while maintaining guidewire position. Also, the Keeper Embolectomy Catheter is another two-in-one device which integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position.
These products are commercially available in the USA.