Clinical Evidence

PRELUDE Study - BTK

Clinical Outcomes

The initial outcomes demonstrate that the Serranator can achieve excellent lumen gain, with minimal dissection and low reintervention rates. (n=53 lesions)

0

Final Residual Stenosis

0

Maximum Pressure (mean)

0

Bailout Stent Rate

0

Freedom from CD-TLR at 6 months

Additionally, dramatic quality of life and Rutherford classification improvements were demonstrated.

Prospective, core-lab adjudicated

The Serranator was found to be safe and effective in treating atherosclerotic disease of the infrapopliteal arteries. The PRELUDE BTK study also showed effective lumen gain with an average pre-procedure diameter stenosis of 81.3%, and an average post treatment diameter stenosis of 21.8%. The lumen gain was achieved using low atmospheric pressure (avg maximum of 6ATM). The mechanism of action was documented by OCT and IVUS. The Serration Angioplasty effect was shown in all 10 lesions imaged. A low re-intervention rate was observed. The Freedom from CD-TLR at 6-months was 97.7%.

(NCT03693963) – https://journals.sagepub.com/doi/10.1177/15266028211059917

Bar chart showing average diameter stenosis reduced from 81.3% pre-treatment to 21.8% post-treatment with Serranator across 53 lesions

Serration Evidence

As part of the PRELUDE Studies, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed on a sub-set of cases. In all cases, imaging demonstrated serrations regardless of plaque morphology. (n=10/10 lesions)

IVUS images showing diffuse circumferential calcification before Serranator treatment and resulting slits enabling lumen enlargement without dissection, per Dr. Akiko Maehara

Pre-intervention imaging showed diffuse circumferential superficial calcification (A-B). Post-Serranator imaging showed slits in the superficial calcium enabling enlargement of lumen without any dissection (A’-B’)” – Dr. Akiko Maehara

OCT images showing serrations created by Serranator device, performed by Dr. Andrew Holden

OCT Shows Serrations – Performed by Dr. Andrew Holden

Bar chart comparing Serranator PRELUDE-BTK residual stenosis of 21.8% to POBA benchmark studies: IN.PACT DEEP 28%, LUTONIX 30%, and BIOLUX P-I 30.5%

All Data is for POBA trials or POBA control arms from other studies; *Average Represents a Combined Weighted Average including all Studies

1. Zeller, T., Baumgartner, I., Scheinert, D., Brodmann, M., Bosiers, M., Micari, A., . . . Rocha-Singh, K. J. (2014). Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia. Journal of the American College of Cardiology, 64(15), 1568-1576. doi:10.1016/j.jacc.2014.06.119

2. Mustapha, J., Brodmann, M., Geraghty, P., Saab, F., Settlage, R., & Jaff, M. (2019). Drug-Coated Versus Uncoated Percutaneous Transluminal Angioplasty in Infra-popliteal Arteries: Six-Month Results of the Lutonix BTK Trial. Journal of Vascular Surgery, 70(5), 1718. doi:10.1016/j.jvs.2019.08.011

3. Zeller T, Beschorner U, Pilger E, Bosier M, Deloose k,... Brodmann M. (2015). Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries).

Angiographic images showing Tibial Peroneal Trunk lesion with 100% stenosis treated with Serranator achieving 22% residual stenosis with no dissection

Tibial Peroneal Trunk

  • Stenosis: 100%

  • Serranator® size: 3 x 40mm

  • Maximum ATM: 6

  • Post residual stenosis: 22%

  • No dissection

Angiographic images showing Proximal and Distal Posterior Tibial lesion with 80% stenosis treated with Serranator achieving 22% residual stenosis with no dissection

Proximal & Distal Posterior Tibial

  • Stenosis: 80%

  • Serranator® size: 3 x 120mm

  • Maximum ATM: 6

  • Post residual stenosis: 22%

  • No dissection

Angiographic images showing Distal Anterior Tibial lesion with 100% stenosis treated with Serranator achieving 15% residual stenosis with no dissection

Distal Anterior Tibial

  • Stenosis: 100%

  • Serranator® size: 2.5 x 120mm

  • Maximum ATM: 4

  • Post residual stenosis: 15%

  • No dissection

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