US-based device company Summa Therapeutics has performed the first injectable angioplasty with its Finesse InjectableTM balloon catheter on patients with peripheral arterial disease (PAD).
The design of the catheter aims to increase the efficiency of peripheral angioplasty, a procedure treating poor circulation in the legs, reducing the risk of amputation.
According to Summa, Finesse InjectableTM is the industry’s first hybrid catheter that combines diagnostic and therapeutic features. The device serves as a crossing catheter, diagnostic angiography catheter, and angioplasty catheter.
The design aims to minimise the requirement for excessive equipment and contrast – when used as a crossing catheter, the Summa Finesse catheter often eliminated the need for microcatheters to navigate arterial obstructions. It also injects contrast on the go, minimising the requirement for contrast material during the procedure. This benefits patients with diabetes and kidney dysfunction, where excess contrast can pose harm.
The first procedures, performed by doctors Rahul Patel and Robert Lookstein at Mt. Sinai hospital in New York City, and John Rundback and Kevin Herman at the Advanced Vascular and Interventional Services office-base laboratory in New Jersey, were the first-in-human procedures using the device.
“All users reported using less contrast and yet angiographic quality was described as excellent. The Summa Finesse Injectable has tremendous market potential and may become the standard of care when treating patients with chronic kidney disease, for whom contrast sparing is paramount,” said Summer Therapeutics CEO Timothy Murphy.
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According to a report on GlobalData’s Medical Intelligence Center, the number of angioplasty procedures in the United States is forecast to reach 2,103,798 in 2030. Minimally invasive interventions have been identified as an area for growth in the US.
Pennsylvania-headquartered company Orchestra BioMed announced plans in August last year to initiate a study of its non-coated angioplasty system, Virtue Sirolimus AngioInfusion Balloon (SAB), to treat coronary in-stent restenosis (ISR) patients. The US Food and Drug Administration (FDA) awarded investigational device exemption (IDE) approval to SAB prior to this.