Jupiter Endovascular Reports Positive Vertex Pulmonary Embolectomy Results

Jupiter Endovascular has announced encouraging pivotal results for its investigational Vertex Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism. The SPIRARE II study met both primary endpoints and showed meaningful improvements in right-heart strain and pulmonary pressure measures, alongside a low major adverse event rate. While the findings point to the platform’s potential in controlled clot removal, the device remains investigational, making cautious optimism the appropriate response at this stage.

Why It Matters

A pulmonary embolism is not merely a clot formation in the lungs. It is a condition where there is cardiovascular stress that can easily become a condition involving the right side of the heart. When a clot causes obstruction in the pulmonary vessels, then the right ventricle needs to work against increased resistance. This can lower the cardiac output, diminish oxygenation, and increase the risk for shock. According to statistics from the CDC, the incidence of venous thromboembolism, which involves DVT and PE, can be up to 900,000 cases annually in the United States, and sudden death may be the initial symptom in 25 percent of patients with PE.

That clinical reality shapes every treatment decision. Anticoagulation remains the foundation of PE care because it prevents further clot growth and lowers the risk of recurrence. In patients who are hemodynamically unstable, systemic thrombolysis remains a major reperfusion option. But in patients who are not yet in shock, the decision gets harder. Current guideline summaries say routine systemic fibrinolysis should be avoided in intermediate-high-risk PE because the bleeding tradeoff is real, especially the risk of major hemorrhage and intracranial bleeding. A widely cited meta-analysis found that thrombolysis was associated with lower mortality in some PE populations, but also with significantly higher rates of major bleeding and intracranial hemorrhage.

Mechanical pulmonary embolectomy tries to solve that problem directly. Instead of dissolving clot throughout the body, the aim is to remove enough obstructing thrombus to improve blood flow, reduce right-sided pressures, and stabilize the patient without full-dose systemic lytics. What makes Vertex different, at least on paper, is the way the catheter is supposed to behave inside the anatomy. Jupiter’s Transforming Fixation platform is intended to let the device move flexibly through the right heart and then stabilize on demand once it reaches the target vessel. In practical terms, the company is arguing that better stability could mean better control, more precise clot removal, and less need for awkward repeat maneuvers in a part of the circulation where access can be challenging.

The pivotal results are also supported by Jupiter’s earlier SPIRARE I feasibility study. In that first-in-human trial, 10 patients with acute, intermediate-risk pulmonary embolism were treated at two European centers, with no major adverse events reported within 48 hours. The study also showed improvements in pulmonary artery pressure, RV/LV ratio, and shortness of breath. While such a small study cannot prove broad effectiveness, it suggested that the device concept could work in real patients. SPIRARE II now builds on that early signal with a larger, multicenter dataset.

In spite of all that, the findings should be taken into account with care. Although SPIRARE II was a prospective, multi-center and pivotal trial, it was conducted in one arm only, which means it cannot confirm that the device is superior to anticoagulation, thrombolysis, or other thrombectomy devices. This point is critical, because the treatment of PE is becoming more scientific nowadays. On the other hand, modern clinical trials have already confirmed that a mechanical thrombectomy allows restoring heart and hemodynamic functions fast.

Who It Affects

Patients with acute pulmonary embolism remain at the center of this story. The Vertex system is being studied in people with acute, intermediate-risk PE, the group that often has right-heart strain without frank circulatory collapse. For these patients, a successful mechanical option could offer faster pressure relief while reducing reliance on high-dose clot-dissolving drugs. That possibility matters even more for people whose bleeding risk makes systemic fibrinolysis a poor fit. At the same time, patients need clear expectations: this is still an investigational device, and the current data support continued evaluation, not routine off-the-shelf use.

Clinicians and PE response teams would feel the impact quickly. Catheter-based PE care rarely belongs to one specialty. Interventional cardiologists, interventional radiologists, vascular specialists, emergency physicians, pulmonologists, intensivists, and imaging teams all help decide who needs advanced therapy and how quickly it should happen. Current guideline comparisons note that multidisciplinary pulmonary embolism response teams are recommended by several major societies. ACC coverage of PE care has also highlighted that PERT models were created to streamline management in a disease with high acuity, growing device options, and historically inconsistent treatment pathways. In simple terms, if Vertex eventually moves into broader use, it will not just add a device. It will add training demands, more decision points, and a stronger need for team-based protocols.

Hospitals and health systems face a practical adoption question. Large tertiary centers with established endovascular programs, ICU support, advanced imaging, and rapid multidisciplinary consultation will probably find it easier to evaluate or adopt a new pulmonary embolectomy platform. Smaller hospitals may rely more on transfer pathways and regional referral networks. That likely means new technology will cluster first in high-resource centers. The broader concern is equity. The American Heart Association has already highlighted disparities in pulmonary embolism diagnosis, treatment strategies, and outcomes, and ACC coverage has pointed to persistent racial and geographic differences in PE mortality. So any future rollout of advanced PE devices will need to think about access, not just innovation.

The payers and regulatory authorities are interested in other endpoints as well. While a physiological endpoint is crucial, it will not help resolve all issues of interest in routine clinical practice. The regulators will require safety and efficacy that can be achieved in all clinical centers and by all operators. The payers will want proof of the impact that the device will have on clinically important outcome measures such as a decrease in rescue treatments, complications, duration of monitoring, and recovery following discharge from hospital. This requirement is getting harder to meet, since the entire field of PEs devices now contains randomized trials as well as registry data on other thrombectomy devices.

What Changes

• The first change is conceptual. In PE care, the conversation keeps moving away from simple clot removal and closer to measurable hemodynamic recovery. The SPIRARE II data reinforce that shift. Clinicians are increasingly asking whether a treatment can quickly unload the right ventricle, lower pulmonary pressures, and improve the physiologic picture within hours or days, not just whether it clears visible thrombus. That makes sense in a condition where right-heart strain often drives the worst outcomes. It also explains why metrics like RV/LV ratio and pulmonary artery pressure have become so important in modern device trials.
• The second change is strategic, but it is not unlimited. Positive Vertex data give more momentum to catheter-based embolectomy in intermediate-risk PE, especially for patients in whom bleeding risk makes thrombolysis less attractive. But current guidance still keeps anticoagulation as the mainstay of treatment and generally reserves catheter-based intervention for rescue settings or for patients with high bleeding risk when advanced reperfusion is needed. So the likely near-term shift is not universal thrombectomy. It is a more serious conversation about which intermediate-risk patients might benefit from earlier catheter-based treatment, and what evidence should be required before that becomes routine.
• The third change relates to operations. With continued improvements in pulmonary embolectomy technology, the way hospitals organize themselves around them is going to have to change too. This implies having more streamlined triage algorithms, rapid transport processes, simulation and operator training, cooperation among emergency medicine, imaging, critical care, and interventional services, and greater follow-up after the patient leaves the hospital. In its recent statement on acute PE management, the ACC emphasized the importance of standardization, registries, and agreed upon end points with regard to pulmonary embolism devices, particularly when it comes to follow up. And the importance of follow-up can be seen as important for another reason: success isn’t measured solely in procedure room efficacy.
• The bottom line is cautious optimism. Jupiter Endovascular has produced a meaningful positive study result for an investigational device built around a real technical challenge in PE intervention: how to navigate the right heart safely and then work with stable control inside the pulmonary arteries. The readout is strong enough to justify attention from PE programs, clinicians, and hospital leaders. But it is not yet the final answer. Until there is broader comparative evidence, real-world durability, and regulatory clearance for pulmonary embolectomy use, Vertex should be viewed as a promising new entrant, not an established replacement for current care pathways. References U.S. National Library of Medicine. Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II (SPIRARE II) (NCT06576427). ClinicalTrials.gov. 2026. https://clinicaltrials.gov/study/NCT06576427 [\[clinicaltrials.gov\]](https://clinicaltrials.gov/study/NCT06576427) Jupiter Endovascular, Inc. Jupiter Endovascular Announces Positive Results from SPIRARE II Pivotal Trial at EuroPCR 2026. Jupiter Endovascular. 2026. https://jupiterendo.com/jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial-at-europcr2026/ [\[jupiterendo.com\]](https://jupiterendo.com/jupiter-endovascular-announces-positive-results-from-spirare-ii-pivotal-trial-at-europcr2026/) Centers for Disease Control and Prevention. Data and Statistics on Venous Thromboembolism. CDC. 2025. https://www.cdc.gov/blood-clots/data-research/facts-stats/index.html [\[cdc.gov\]](https://www.cdc.gov/blood-clots/data-research/facts-stats/index.html) Shahriar AA, Paul J, Cifu A. Endovascular management of intermediate-risk pulmonary embolism: evidence, outstanding questions, drivers of utilization, and the horizon. Eur Heart J Open. 2025;5(3):oeaf071. https://pmc.ncbi.nlm.nih.gov/articles/PMC12188119/ [\[pmc.ncbi.nlm.nih.gov\]](https://pmc.ncbi.nlm.nih.gov/articles/PMC12188119/)