The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems available in Europe. The company’s latest offerings set to hit the European market follow the launch of two new stroke catheters there earlier this year.
“Based on outcomes from our clinical trials and from physicians using our devices globally, our CAVT technologies have greatly improved our ability to rapidly and safely remove clot in the vascular system,” said Dr. James F. Benenati, chief medical officer at Penumbra. “With quicker procedures and more efficient clot removal, we have improved outcomes while demonstrating a high level of safety. As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 and Lightning Bolt 7 will provide physicians in Europe with the confidence that CAVT is a valuable first-line option to manage conditions such as PE, venous thrombosis, and acute limb ischemia.”
More about the new thrombectomy offerings from Penumbra
Lightning Flash 2.0, a mechanical thrombectomy system, addresses venous and pulmonary thrombus. It features Penumbra’s Lightning Intelligent Aspiration technology and the latest dual clot detection algorithms. Those algorithms utilize both pressure- and flow-based processes to detect blood clot and blood flow.
The company developed the Lightning Flash 2.0 catheter from its MaxID hypotube technology. This allows for an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip design. The offering also features streamlined audio-visual feedback to give physicians a better understanding of what happens at the tip of a catheter during a procedure. Penumbra won FDA clearance for Lightning Flash 2.0 earlier this year.
Lightning Bolt 7, an arterial thrombectomy system, introduces a new method for removing blood clots. This method — modulated aspiration — pairs the Lightning Intelligent Aspiration technology with an advanced microprocessor algorithm. The pairing enhances the ability to rapidly remove large, fibrous blood clots in the arteries with minimal blood loss. The company said this addresses conditions such as acute limb ischemia (ALI), hibernating thrombus and visceral occlusions.
Penumbra designed Lightning Bolt 7 to detect the difference between blood clot and blood flow. It can also break the friction between the catheter and clot as algorithms rapidly modulate aspiration. This quickly fatigues the thrombus, removing the clot from the arteries. Meanwhile, it facilitates maximum vacuum force at the catheter itp for optimal, rapid ingestion of blood clots.
