PINNACLE I Outcomes Presented for Elixir Medical’s LithiX Hertz Contact IVL System

May 20, 2024—Elixir Medical recently announced that the PINNACLE I study met its primary endpoint for clinical success. PINNACLE I is evaluating the safety and performance of Elixir Medical’s LithiX Hertz Contact intravascular lithotripsy system (IVL) for the treatment of moderate to severely calcified coronary artery lesions. Clinical success in the study was defined as optimal stent expansion after final treatment with no in-hospital major adverse cardiovascular event (MACE). The primary safety endpoint was MACE through 30 days. Primary safety and effectiveness will continue to be reported through 6 months, advised the company.

The company recently announced that the data were presented at EuroPCR 2024, which was held May 14-17 in Paris, France.

Elixir Medical stated that its transcatheter LithiX Hertz Contact IVL system is designed to address challenges associated with the percutaneous treatment of nodular, concentric, and eccentric moderate to severe calcified lesions resistant to optimal stent expansion. The system is composed of multiple discrete metal hemispheres incorporated on a semicompliant balloon. It is designed to deliver calcium fragmentation for a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress contact points.

According to the company, PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact IVL system for the treatment of calcified lesions. The trial is composed of 60 patients enrolled at five sites in Belgium and the Netherlands. Optical coherence tomography (OCT) images of 32 patients were analyzed in an imaging substudy, which was conducted to accurately assess lesion complexity and the calcium fragmentation effectiveness of the LithiX system. The angiographic and intravascular imaging results were adjudicated by an independent core lab.

As summarized in Elixir Medical’s press release, the study demonstrated 98.3% clinical success of primary safety and effectiveness with 100% angiographic success across a broad range of moderate to severe calcium morphologies including eccentric, concentric, and nodular calcifications. Residual diameter stenosis of < 50% and < 30% was achieved in 100% of the lesions. Safety was demonstrated with only one periprocedural non-Q-wave myocardial infarction resulting in a 1.7% MACE event rate through 30 days. No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure postprocedure.

In the OCT substudy, calcification severity was confirmed with 263.4º of maximum continuous calcium arc and 23.9-mm average calcium length. Calcium nodules were present in 31% of the lesions. There was a very high lesion fracture rate with significant depth and width of fractures: >90% of lesions with documented fractures and 75% of lesions having two, three, or more fractures; 0.8 ± 33 mm average fracture depth and 0.66 ± 29 mm average fracture width. The device exhibited optimal final stent expansion with high stent area by all measurement classifications: 103.4% stent expansion at maximum calcium site and 96.7% stent expansion at minimum stent area site, reported the company.

Elixir Medical stated that the PINNACLE I data validate the development of Hertz Contact IVL as an effective and safe treatment option for patients with short procedure time, simple learning curve, and utility in the treatment of a broad range of moderate to severe calcified lesions. Primary safety and effectiveness will continue to be reported through 6 months.

“The PINNACLE I data are particularly exciting because they clearly demonstrate LithiX IVL’s ingenious and intuitive IVL mechanism of action, which is hard on calcium and atraumatic on the soft tissue,” commented Stefen Verheye, MD, in the company’s press release. “The multitude of clearly visible and deep fractures, which exceeded our expectations, contributed to the optimal and uniform final stent expansion.”

Dr. Verheye, who is an interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium, added, “Ease of use and simple integration of the device into physician’s workflow also helps shorten the learning curve and procedure time, and reduces radiation exposure for the patient which is of significant value in these complex interventions.”