Clinical Data

The Serranator has been studied in both the above-the-knee and below-the-knee anatomy. Our clinical trials were prospective, core-lab adjudicated, 100% data monitored studies that were published in peer-reviewed journals.

PRELUDE ATK Study Summary

The Serranator® 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® 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.

(NCT03001700) – https://journals.sagepub.com/doi/pdf/10.1177/1526602818820787

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The Serranator® 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® 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.

(NCT03001700) – https://journals.sagepub.com/doi/pdf/10.1177/1526602818820787

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 subjects)

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IVUS: “Controlled modification of severe intimal calcification by the Serranator®. Note the controlled acute luminal gain of the impacted calcified intimal layer.”

– J. Mustapha, MD

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OCT: “Shows clear evidence of serration caused by the Serranator® device.”

– A. Holden, MBChB, FRANZCR, EBIR

Clinical Outcomes

The initial outcomes demonstrate that the Serranator can achieve excellent lumen gain, with minimal dissection and low reintervention rates. (n=25 subjects)

22.7%

Final Residual Stenosis

7.9 ATM

Maximum Pressure (mean)

4%

Bailout Stent Rate

100%

Freedom from CD-TLR/TVR at 6 months

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

Case Examples

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Right Proximal Popliteal with Total Occlusion

  • RVD: 4.19mm
  • Lesion length: 54.28mm
  • Stenosis: 100%
  • Serranator® size: 5 x 80mm
  • Inflation pressure: 6 ATM
  • Post-treatment residual stenosis: 20.23%
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Right Distal SFA with Severe Calcification​

  • RVD: 6.12mm
  • Lesion length: 30.04mm
  • Stenosis: 94.59%
  • Serranator® size: 6 x 40mm
  • Inflation pressure: 11 ATM
  • Post-treatment residual stenosis: 24.07%
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Left Mid SFA​

  • RVD: 5.15mm
  • Lesion length: 28.42mm
  • Stenosis: 77.02%
  • Serranator® size: 5 x 40mm
  • Inflation pressure: 6 ATM
  • Post-treatment residual stenosis: 12.84%

PRELUDE BTK Study Summary

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

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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

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)

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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

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OCT Shows Serrations

– Performed by Dr. Andrew Holden

Clinical Outcomes

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

21.8%

Final Residual Stenosis

6 ATM

Maximum Pressure (mean)

1.9%

Bailout Stent Rate

97.7%

Freedom from CD-TLR at 6 months

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

25%

Final Residual Stenosis improvement over POBA

Final residual stenosis of PRELUDE BTK (21.8%) compared to other core lab adjudicated studies (29.1%*)

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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).

Case Examples

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Tibial Peroneal Trunk

  • Stenosis: 100%
  • Serranator® size: 3 x 40mm
  • Maximum ATM: 6
  • Post residual stenosis: 22%
  • No dissection
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Proximal & Distal Posterior Tibial

  • Stenosis: 80%
  • Serranator® size: 3 x 120mm
  • Maximum ATM: 6
  • Post residual stenosis: 22%
  • No dissection
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Distal Anterior Tibial

  • Stenosis: 100%
  • Serranator® size: 2.5 x 120mm
  • Maximum ATM: 4
  • Post residual stenosis: 15%
  • No dissection

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