Hotspur Technologies, Inc. announced today that it has received FDA clearance for the first three commercial products in its portfolio. These products are based on Hotspur's unique and groundbreaking technology that makes dialysis access interventional and peripheral vascular procedures that open blood vessels less expensive, more efficient, and less invasive for patients.
These new Hotspur devices are focused on solving some of the key challenges resulting from two types of medical procedures for restoring bloodflow: opening the blood vessels or grafts needed by patients who have regular dialysis; and opening blocked vessels in arms and legs. In both of these instances, physicians must use multiple catheters to clear the blood vessels. Until now, these dialysis access interventions and peripheral vascular procedures have required insertion of a separate catheter. This is time-consuming and expensive. Hotspur's products enable insertion of only one catheter for the entire procedure.
"We are excited about the benefits our technologies will bring in peripheral and dialysis access interventions," said Gwen Watanabe, President and CEO of Hotspur Technologies. "Making peripheral vascular procedures faster and more efficient so that doctors can perform more cases and patients can get out of the interventional suite or the dialysis access centers more quickly is the focus of our innovations."
Watanabe further explained the need for these Hotspur devices:
In dialysis, when patients receive ongoing treatment, they regularly need to check and clean the access point for clots, damage, and limited access. Traditionally, this procedure requires multiple catheter insertions. With Hotspur, only one insertion is needed for the whole process resulting in reduced time and cost.
Peripheral arterial disease (PAD) and blood clots in the arms and legs affect more than 30 million people worldwide. PAD develops most often as a result of the hardening of arteries (atherosclerosis) which causes the arteries to narrow and restrict blood flow. This condition is most often treated with angioplasty, a minimally invasive procedure that uses a catheter and balloon to widen narrowed or blocked peripheral arteries. Unlike existing angioplasty balloons, the Hotspur devices enable physicians to conduct multiple functions with one catheter.
The three Hotspur products that have received FDA clearance are: