Dive Brief:

• Penumbra is launching a new arterial thrombectomy system, called Lightning Bolt 7, after receiving clearance from the Food and Drug Administration in March. 
• The system uses modulated aspiration to remove blood clots and pressure sensors paired with an algorithm to detect when the device is drawing in the clot or blood. 
• With the Lightning Bolt 7 offering and the recent launch of another vascular device, Lightning Flash, Alameda, Calif.-based Penumbra expects 2023 revenue growth of 23% to 25%.

Dive Insight:

Penumbra says its Lightning Bolt 7 system, paired with its built-in algorithm, is able to remove large, fibrous clots in the arteries with minimal blood loss, addressing conditions where a blockage restricts blood flow to the limbs, or to the intestines, spleen and liver.

These conditions often require open surgery and can result in amputation, Kalyan Veerina, an interventional cardiologist at Cardiovascular Institute of the South, said in a statement issued by Penumbra.

“Even though it is early, we are already starting to see conversion to Lightning Bolt 7 from physicians who might historically have performed open surgery or lytics,” Penumbra CEO Adam Elsesser said in a May earnings call. 

Elsesser shared a story of a recent procedure where a patient had a complete blockage of a stent in her superficial femoral artery. While the patient was scheduled for an amputation, the physician decided to try Penumbra’s device prior to the surgery and was able to clear up the clot completely with the patient likely to keep her foot and leg. 

“With this breakthrough technology, we have a rare opportunity to convert a large number of physicians to Lightning Bolt 7 from traditional modes of treating arterial thrombus,” Elsesser said. “But we understand that we have a lot of work ahead of us.” 

Raghu Motaganahalli, a vascular surgeon with Indiana University Health Physicians, explained how the new device would help doctors treat blood clots without surgery.

“The computer-aided components offer a safety profile that, when combined with the clot removal speed and efficiency, will promote an endovascular-first approach for a broader range of cases before considering open surgery,” he said in the statement from Penumbra.

Elsesser said that while material costs for Lightning Bolt is higher than an open surgery, once the procedure time and length of patient stay are taken into consideration, “we have a pretty compelling argument that we are significantly more cost effective.” 

The company’s goal is to bring its technologies to physicians treating more than 800,000 pulmonary embolism and arterial patients in the U.S.