Clinical Data

The Serranator® Alto met its safety and efficacy endpoints in a preliminary study for the treatment of femoro-popliteal disease. There was 100% device technical success. The acute results of this feasibility study demonstrate that the Serranator® Alto can safely achieve low residual stenosis. Successful lumen gain was achieved with an average post diameter stenosis of 23%, from a pre-procedure of 88%. In a majority of subjects (68%), the lumen gain was achieved with only 6 ATM of pressure. Serrations were documented by OCT or IVUS in all subjects (n=10) who underwent post Serranator imaging.

PRELUDE Study Summary

The PRELUDE Study (Prospective Study for the treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery Using the Serranator Device) was a single-arm, prospective, multicenter feasibility study that enrolled 25 subjects with superficial femoral or popliteal lesions.

Publication: Holden, et al. PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries. Journal of Endovascular Therapy. 2019: Vol 26(1): 18-25.

PRELUDE Conclusions​

  • Serranator® Alto met its safety and efficacy endpoints in treating femoro-popliteal lesions in study patients (n=25)
  • 100% technical success (n=25)
  • 100% confirmation of serration effect by OCT and IVUS (n=10)
  • Acute results show that Serranator® Alto can achieve low residual stenosis
  • Serranator® Alto showed effectiveness in moderate to severe calcification
  • Majority of subjects successfully treated at low pressure inflation

Investigators

Andrew Holden, MBChB, FRANZCR, EBIR (PI)
Auckland, New Zealand

Marianne Brodmann, MD
Graz, Austria

Marek Krzanowski, MD
Kraków, Poland

Przemyslaw Nowakowski, MD
Chrzanów, Poland

Case Examples

Right Proximal Popliteal with Total Occlusion

Right Proximal Popliteal with Total Occlusion
  • RVD: 4.19mm
  • Lesion length: 54.28mm
  • Stenosis: 100%
  • Serranator® Alto size: 5 x 80mm
  • Inflation pressure: 6 atm
  • Post-treatment residual stenosis: 20.23%

Right Distal SFA with Severe Calcification​

Right Distal SFA with Severe Calcification​​
  • RVD: 6.12mm
  • Lesion length: 30.04mm
  • Stenosis: 94.59%
  • Serranator® Alto size: 6 x 40mm
  • Inflation pressure: 11 atm
  • Post-treatment residual stenosis: 24.07%

Left Mid SFA​

Left Mid SFA​​
  • RVD: 5.15mm
  • Lesion length: 28.42mm
  • Stenosis: 77.02%
  • Serranator® Alto size: 5 x 40mm
  • Inflation pressure: 6 atm
  • Post-treatment residual stenosis: 12.84%

PRELUDE Study OCT &
IVUS Images Show Serration Effect​

Evidence-of-serration-IVUS
IVUS*: “Controlled modification of severe intimal calcification by the Serranator® Alto.  Note the controlled acute luminal gain of the impacted calcified intimal layer.” – J. Mustapha, MD
Evidence of serration OCT
OCT*: “Shows clear evidence of serration caused by the Serranator® Alto device.” – A. Holden, MBChB, FRANZCR, EBIR