Advances in technology are changing the way serious blood clots like pulmonary embolism (PE) are treated. Anticoagulant and thrombolytic therapy have been the standard of care, however, it may take days, weeks or months1 to dissolve the clots and can come with a host of potential complications. Over the past decade, advancements in technology have allowed for the development of potentially safer, quicker and more efficient clot removal methods for patients.
Mechanical thrombectomy pioneer Penumbra Inc. is at the forefront of this new era in PE treatment. When Penumbra was founded, it was one of the first companies focused on a minimally invasive approach to removing blood clots quickly. The company created a first-to-market “vacuum-like” technology designed to quickly and efficiently remove blood clots in the brain and later adapted the technology to remove blood clots throughout the body including the heart and lungs.
As part of the company’s commitment to advancing patient care, Penumbra is highly focused on innovations that address challenging and/or underserved conditions where there is a significant impact on patient outcomes and quality of life. The story of Elizabeth Simms, a 27-year-old expectant mother, is just one example of the impact of the company’s technologies.
Pulmonary Embolism Puts Two Lives at Risk
When Simms was pregnant with her fourth child, she didn’t think anything was wrong when she began experiencing shortness of breath and a rapid heart rate at 31 weeks, attributing the symptoms to her advanced pregnancy. However, when they did not dissipate, her husband insisted she go to the emergency room, where she was diagnosed with a PE.
During pregnancy, a woman’s body changes so that it forms blood clots more easily, lessening the risk of blood loss during labor and delivery. This increase in clotting ability is estimated to result in 1 in 1,000 pregnant women experiencing serious blood clots, making them a leading cause of maternal death.2
In the ER, Elizabeth’s health was rapidly declining, and her vitals became unstable. Medical professionals from across the hospital’s various departments, including obstetrics, surgery and pulmonology, were consulted to find a way to save her and not risk the life of her baby.
“When Elizabeth arrived, her medical condition was touch and go,” said Dr. Robert Cirillo, an interventional radiologist at Owensboro Health Regional Hospital in Kentucky. “At one point it seemed she might not make it through the night since she was not a candidate for traditional medical therapy (anticoagulants) or thrombolytics given her pregnancy. We knew that we needed to remove the blood clot quickly, and Penumbra’s Indigo® system enabled us to do so without jeopardizing the health of the baby. Penumbra continues to deliver non-invasive and often life-saving technologies that allow me to improve patient outcomes.”
Within minutes of the procedure, Simms’ symptoms disappeared, and her condition stabilized.
Removing Blood Clots with “Computer-Aided” Technology
Penumbra’s Lightning technology uses mechanical thrombectomy to remove blood clots in the body. The latest iteration of the Indigo System uses Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood; it is designed to remove blood clots and leave healthy blood circulating.
During an aspiration thrombectomy procedure, an interventionalist guides a catheter through the patient’s veins to the clot. Once the thrombectomy catheter is in place, the catheter is connected to Penumbra’s novel vacuum pump and computer system to extract the thrombus. Once the clot is removed, blood flow is restored immediately – potentially helping to improve quality-of-life, breathing scores and other functional outcomes.3
Advances in design provide aspiration thrombectomy catheters that are more torqueable and trackable, enabling target vessels to be reached more efficiently. These advancements offer a solution that typically takes less time than a thrombolytics only approach, which may allow patients to leave the hospital faster.
Efficacy of Aspiration Thrombectomy Validated in Clinical Studies
Studies have shown the success of aspiration thrombectomy in many different applications. In 2021, results of the first prospective study of the Indigo System were published, demonstrating its safety and efficacy for patients with acute PE.4 This year, initial prospective data was presented suggesting that the Indigo System with Lightning is safe and effective for treating PE and can also improve a patient’s functional outcome and quality-of-life.3 Penumbra also initiated STORM-PE, a randomized controlled trial comparing mechanical thrombectomy, using Penumbra’s Indigo® Aspiration System, with anticoagulation versus anticoagulation alone for the treatment of intermediate-high risk acute pulmonary embolism, which may inform future treatment guidelines to include mechanical thrombectomy as a frontline treatment option.
For more information about mechanical thrombectomy, visit www.penumbrainc.com.
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1 Goldhaber SZ. Pulmonary embolism. N Engl J Med. 1998;339:93-104.
2 Simcox LE, Ormesher L, Tower C, Greer IA. Pulmonary thrombo-embolism in pregnancy: diagnosis and management. Breathe (Sheff). 2015 Dec;11(4):282-9.
3 Weinberg, I. Periprocedural and Patient-Reported Quality of Life Outcomes After Computer-Aided Mechanical Aspiration Thrombectomy for the Treatment of Acute Pulmonary Embolism. Presented at: VIVA 22 Oct. 31 – Nov. 3, 2022; Boston, MA.
4 Sista A, Horowitz J, Tapson V, et al. Indigo Aspiration System for Treatment of Pulmonary Embolism. J Am Coll Cardiol Intv. 2021 Feb, 14 (3) 319–329.