On November 20, 2020, Penumbra’s newest generation of Indigo Aspiration System, Lightning 12, received FDA clearance for the treatment of pulmonary embolism (PE).

GlobalData estimates that in 2019, almost 200,000 cases of PE occurred in the US alone, and this incidence has increased during the COVID-19 pandemic. The majority of patients receive pharmaceutical treatment for the disease; however, of the PE patients receiving endovascular treatment, over half were estimated to have undergone thrombectomy using aspiration thrombectomy systems such as the AngioJet system from Boston Scientific.

The outbreak of COVID-19 has affected many markets across medical devices. While the incidence of PE has increased during the pandemic, GlobalData has estimated that the number of endovascular procedures for clot management has experienced a low single-digit decline in the US for 2020. However, given the urgent and life-threatening nature of PEs, the impact on endovascular procedures has been minimal compared to other markets. Penumbra reported a 43% increase in revenues in its vascular business, largely driven by the Indigo System and strong performance from the launch of its Lightning 12 system in July. The expansion of indications will likely further drive growth for Penumbra, particularly as peripheral markets continue to recover in Q4.

Penumbra’s Indigo Aspiration System is currently the market leader in the US. The approval for expanded indications allows Penumbra to enter the endovascular pulmonary embolism treatment market, where thrombectomy systems are the most frequently used, and is expected to grow steadily at a compound annual growth rate (CAGR) of 1% over the next ten years. With the Indigo Aspiration System leading with the lion’s share of the thrombectomy systems market, GlobalData expects that Boston Scientific may have difficulty holding onto its market share in the coming years.