Penumbra Rolls Out Lightning Flash 3.0 Thrombectomy System

Penumbra has launched its Lightning Flash 3.0 computer-assisted vacuum thrombectomy (CAVT) system, which includes upgrades that advance its venous thromboembolism (VTE) platform.

The Flash 3.0 algorithm was designed for enhanced clot detection capabilities with more sensitivity to thrombus and blood. It includes enlarged tubing paired with an automated backflush feature tailored for large thrombus burdens, as well as to reduce friction from aspirated thrombus.

The improvements result in 1.3x faster clot removal time, according to the company. It also provides 60% fluid savings and an upgraded user interface with streamlined audio-visual feedback, including a visual display with vacuum and flow indicators.

“On the heels of the positive STORM-PE results, the launch of Lightning Flash 3.0 demonstrates Penumbra’s commitment to continuous innovation and improvement. Our ongoing optimization of our microprocessor algorithms and catheter technology results in an improved physician experience and more efficient clot removal,” said Shruthi Narayan, president of Penumbra. “Our innovation of CAVT underscores our dedication to advancing patient care so that more patients suffering from these complicated conditions can benefit from this advanced technology.”

The company’s STORM-PE trial found use of its CAVT technology with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high risk pulmonary embolism (PE). Penumbra said this marked the first Level 1 evidence showing superior results for mechanical thrombectomy over traditional anticoagulation to treat PE.

“Aspiration with Flash 3.0 allows physicians to optimize thrombus removal with continued improvements in procedure time while simultaneously minimizing blood loss. These advances may translate to significant improvements in patient safety and efficiency for physicians performing these procedures,” said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. “Along with the recent landmark STORM-PE findings, Lightning Flash 3.0 will provide physicians with the confidence that CAVT is a valuable frontline option and will allow for a more rapid adoption of thrombectomy.”

Earlier this month, the company revealed it began a deal with Boston Scientific to be acquired in a transaction that values Penumbra at $374 per share, reflecting an enterprise value of about $14.5 billion.