FDA News

Atherectomy system for small vessel PAD receives FDA clearance

Avinger announced that an image-guided atherectomy system for the diagnosis and treatment of patients with peripheral artery disease received 510(k) clearance from the FDA.

The system (Pantheris SV, Avinger) is an updated version of a previous system (Pantheris, Avinger) that was cleared for marketing by the FDA in July 2018. This newer version has a longer length and lower profile, allowing it to be used in small vessels between 2 mm and 4 mm in diameter, according to a press release from the company. It also includes an enhanced cutter design, stiffer shaft and a refined optical CT imaging system.

“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease,” Jaafer Golzar, MD, chief medical officer of Avinger, said in the press release. “Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk population. Pantheris SV uses a combination of directional atherectomy with onboard image guidance to provide several potential clinical advantages including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury and precise vessel measurement capabilities.”

Avinger announced that an image-guided atherectomy system for the diagnosis and treatment of patients with peripheral artery disease received 510(k) clearance from the FDA.
Source: Adobe Stock

The system will be released as a limited launch in several sites in the United States once it becomes commercially available, according to the release.

Disclosure: Golzar is an employee of Avinger.

 

Avinger announced that an image-guided atherectomy system for the diagnosis and treatment of patients with peripheral artery disease received 510(k) clearance from the FDA.

The system (Pantheris SV, Avinger) is an updated version of a previous system (Pantheris, Avinger) that was cleared for marketing by the FDA in July 2018. This newer version has a longer length and lower profile, allowing it to be used in small vessels between 2 mm and 4 mm in diameter, according to a press release from the company. It also includes an enhanced cutter design, stiffer shaft and a refined optical CT imaging system.

“This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease,” Jaafer Golzar, MD, chief medical officer of Avinger, said in the press release. “Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk population. Pantheris SV uses a combination of directional atherectomy with onboard image guidance to provide several potential clinical advantages including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury and precise vessel measurement capabilities.”

Avinger announced that an image-guided atherectomy system for the diagnosis and treatment of patients with peripheral artery disease received 510(k) clearance from the FDA.
Source: Adobe Stock

The system will be released as a limited launch in several sites in the United States once it becomes commercially available, according to the release.

Disclosure: Golzar is an employee of Avinger.