The US Food and Drug Administration (FDA) has given 510(k) clearance to Spectranetics‘ peripheral atherectomy products, Turbo-Tandem and Turbo Elite, used to treat in-stent restenosis (ISR).
Approval is based on data from the ‘excImer laser randomised controlled study for treatment of femoropopliteal (arteries above and behind the knee) in-stent restenosis’ (EXCITE ISR) clinical trial.
Spectranetics said it received positive statistical result in terms of safety and efficacy during a trial of the products on 250 patients earlier this year.
Genesis Heart Institute principal investigator Eric Dippel said: “With mean lesion length at 20cm, approximately one-third of the patients being re-treated for ISR and also approximately one-third with total occlusions, EXCITE represents a very sick, real-world patient set.
“The highly superior outcomes for both safety and efficacy and the delta in procedural success rates between the two arms of the trial are compelling.
“Given that a significant number of patients today are treated with PTA alone with very poor outcomes, EXCITE demonstrates a proven treatment algorithm that physicians and their patients need.”
Initially, 318 patients were planned to be enrolled for randomised prospective EXCITE ISR trial at up to 35 sites.
Spectranetics president and CEO Scott Drake said: “FDA-clearance of our peripheral atherectomy devices to treat ISR is a landmark moment for Spectranetics and patients worldwide.
“We are the only company with indicated devices, our primary competitors are contraindicated; we possess clinical data that will change clinical practice and a scaled commercial team to capitalize on this $750m market opportunity.”
The trial demonstrated superior safety and efficacy of laser atherectomy with adjunctive PTA compared with PTA alone.
It also showed a 94% procedural success rate using laser atherectomy with PTA versus 83% with PTA alone.
The primary efficacy endpoint of the trial is freedom from TLR through six months, while the primary safety endpoint is freedom from major adverse events (MAEs) at 30 days.