Fe bruary 1, 2021
PRELUDE-BTK Study was presented at this year’s LINC Symposium on January 29th. PRELUDE-BTK Study, was a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of Serration Angioplasty.
The study was led by co-Principal Investigators, Drs. Andrew Holden (Auckland, New Zealand), who presented the data, and Michael Lichtenberg (Arnsberg, Germany). Four other centers from Europe participated in the trial which included 30-day and 6-month follow up.
The Serranator PTA Serration Balloon Catheter is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). The device is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
Forty-six subjects were treated with the Serranator device and 53 lesions were analyzed by the core lab. The average final residual stenosis was 21.8%, with an average BTK arterial lumen gain of 1.55mm. These results were achieved with a low average maximum atmospheric pressure of 6 atmospheres. The bailout stent rate was 1.9%. A subset of lesions (n=10) were imaged with OCT and IVUS and analyzed by a core lab. All showed a serration effect. At 30 days the freedom from primary safety events was 95.7%. The freedom from clinically driven-TLR was 97.7% with 70% of subjects achieving 1 or more RCC improvement at 6 months. There were no Serious Adverse Events related to the device.
“Today, we have insufficient data for effective lesion revascularization in BTK arteries. Based on published POBA data, especially in calcified lesions, more than 40% of the cases result in complex dissections and significant recoil phenomenon. This ultimately leads to scaffold implantation to stabilize the lumen and prevent diminished outflow. This revascularization strategy is associated with poor patency outcomes,” stated the study’s Co-PI, Dr. Michael Lichtenberg.
“The PRELUDE study clearly proved the hypothesis, that hemodynamic and morphologic success in BTK revascularization is strongly associated with vessel compliance improvement. We need to concentrate first on this aspect, before we can discuss the need for longer-term restenosis prevention with antiproliferative substances. We know that dissections are directly associated with loss of patency and impaired wound healing. Prevention of dissections within a rigid, non-compliant vessel, along with luminal gain can only be successful with a vessel wall modification device that applies low atmospheres. The PRELUDE-BTK study clearly showed that the mechanism of action works well enough that it does not even need additional antiproliferative treatment, as CD-TLR was only 2.3% after 6 months,” continued Dr. Lichtenberg.
Carol A. Burns, President and CEO of Cagent Vascular added, “These study data confirm that the Serranator device has a unique mechanism of action that led to these positive results. The concept of adding serrated strips to a balloon is vastly different from a plain balloon. Serration technology with point force capability is the innovation that we have desperately needed for decades old angioplasty. This may change how all angioplasty is performed in the future. The product was recently launched in the US and the EU. The clinical feedback and acute outcomes from users outside the trial appear to replicate these study data. As we expand our commercial efforts, we look forward to making this technology accessible to more physicians to help treat patients afflicted with CLTI.”
Dr. Venita Chandra, Vascular Surgeon from Stanford University added, “I have been very impressed with the luminal gain that can be achieved at low atmospheric pressures provided by serration angioplasty, even in heavily calcified vessels. In addition, the luminal gain in the setting of minimal dissection, and less vessel recoil than POBA, makes this a very compelling new tool for BTK disease. I also think this is a very promising tool for pedal arch angioplasty.”
The Serranator product offering for the infrapopliteal indication is available in 2.5, 3.0, 3.5mm balloon diameters and 40, 80 and 120mm balloon lengths. The Company has initiated US and EU sales and plans to expand its commercial efforts later this year.