Avinger receives FDA 510(k) clearance for Pantheris

276

On 14 October 2015, Avinger announced that it has received 510(k) clearance from the FDA to commence US commercialisation of its Pantheris image-guided atherectomy system for the treatment of patients with peripheral arterial disease. Pantheris combines directional atherectomy with real-time, intravascular visualisation and is designed to empower physicians to precisely remove plaque from blocked arteries, while avoiding disruption of normal arterial wall structures.

“On behalf of all the employees at Avinger, I want to first thank all of the patients who agreed to participate in the VISION trial. It is obvious the clearance today of Pantheris for commercial launch in the US could not have happened without the physicians and hospital staffs who so diligently performed in the VISION trial. I extend my thanks to all of them. I recognise this is only the beginning, but my hope is this is the first small step in the beginning of a revolution that will lead to better acute and long-term outcomes for peripheral arterial disease patients using an imaging modality that does not rely on radiation,” said John Simpson, founder and executive chairman of Avinger. “With the availability of Pantheris, doctors can now have real-time images from the catheter tip which will allow them to better target and treat the parts of the artery that are obstructing blood flow while sparing the normal parts of the artery. This provides physicians a compelling alternative to existing devices in the majority of peripheral arterial disease procedures.”

Clearance of Pantheris comes on the heels of completion of the VISION IDE trial in which Pantheris exceeded the study’s safety and efficacy endpoints. Six-month results from an interim analysis of 93 patients out of the 130 patients treated per protocol in the study were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on 13 October 2015. Data from this interim cohort was the basis for the 510(k) application Avinger submitted to the FDA on 12 August 2015.

Previously released VISION results demonstrated:

  • Residual stenosis of less than or equal to 50% was achieved in 96% of lesions following standalone treatment with Pantheris, surpassing the primary efficacy endpoint performance goal of 87%;
  • Target lesion revascularisation rate of 10.8% and overall major adverse event rate of 21.5% through six-month follow-up in the interim analysis cohort, measuring below the predefined study limit for major adverse events of 43.2%;
  • Zero clinically significant dissections or perforations during the Pantheris procedure;
  • Statistically significant improvement across all patients in both blood flow measurement (ankle brachial index) and symptom-based outcomes (Rutherford classification); and
  • Stent placement in only 4% of lesions following treatment with Pantheris.

Histologic results are expected to be a key differentiator in the VISION trial. These findings will be used to further support the Avinger hypothesis that minimising arterial wall disruption during therapy promotes reduced adjunctive treatments, improved long-term arterial patency, and ultimately minimises the need for reintervention. The average per cent area of adventitia, an indicator of arterial wall disruption, in the atherectomy tissue samples collected was just 1% across all lesions treated and analysed for histology.

“This achievement represents our continued commitment to bring to market the most advanced technology for physicians and their patients affected by peripheral arterial disease,” said Jeff Soinski, chief executive officer of Avinger. “Pantheris received the CE mark during the second quarter of this year, which has provided an excellent opportunity for us to gain additional clinical experience in Europe with enhanced versions of Pantheris designed to improve user interface and streamline the procedure. We anticipate broad-scale commercial launch of an enhanced version of Pantheris in the USA within the first quarter of 2016, following receipt of the appropriate regulatory approvals.”