NeVa CLEAR Study Results Presented at ESMINT: Innovative Thrombectomy Device Achieves Notable First-Pass Success and Patient Outcomes
Primary results from the CLEAR Study(1) were presented at the ESMINT annual meeting in Marseille, France (4-6 September 2023), where Vesalio also announced the fifth anniversary of the international commercialization of the NeVa™ device.
Dallas, TX, September 21, 2023 --(PR.com)-- The NeVa CLEAR Study is a prospective, multicenter, open-label, single-arm, FDA-regulated IDE trial evaluating the safety and effectiveness of Vesalio’s technologically advanced NeVa device, renowned for its capacity to retrieve all clot types in large vessel occlusion (LVO) stroke. Primary results from the study were presented at the ESMINT annual meeting in Marseille, France (4-6 September 2023), where Vesalio also announced the fifth anniversary of NeVa’s international commercialization, making this milestone a dual celebration for the Vesalio team.
The CLEAR Study has been submitted to FDA for clearance of the NeVa device, which is now pending with the FDA. The NeVa device has been available throughout Europe and other international markets for five years, where it is indicated in LVO stroke, a leading cause of death and long-term disability worldwide. Whereas endovascular clot removal has been established as the gold standard treatment for LVO stroke(2), conventional stent retriever technology has proven unsuccessful when patients present with large, hard clot varieties(3). In contrast, NeVa’s Drop Zone™ technology has been designed to extract all clot types(4,5), addressing a significant unmet clinical need for patients suffering from this life-threatening condition.
Since the NeVa launch in CE markets in 2018, several academic publications have highlighted the device’s safety and high first-pass recanalization rates(6,7,8,9), widely accepted as a consistent predictor of positive patient outcomes.10 More recently, the results of the prospective, multicenter, FDA-regulated CLEAR Study affirmed the safety and effectiveness of NeVa, which demonstrated promising first-pass rates and patient outcomes in line with previous publications(11,12,13). The CLEAR Study also showed excellent clinical outcomes, with nearly 2 out of 3 patients treated being functionally independent at 90-day follow-up. Safety results highlighted that trial participants experienced low complication rates and mortality.
"The prospective CLEAR Study confirms the value and differentiation of the NeVa device compared to other stent retrievers for achieving rapid and effective revascularization," said Prof. Dr. Serdar Geyik, who presented the results at the recent ESMINT Meeting. "The results represent a step forward for improving patient outcomes after thrombectomy."
"The results of the CLEAR Study are no surprise to stroke teams who have access to our technology in CE-accepting markets,” said Diane Tangun, VP of Market Development at Vesalio. “We want to thank physicians for recognizing the added value of NeVa and making it part of their neuro-interventional arsenal.”
Ms. Tangun also said, “The fifth anniversary of NeVa’s commercialization marks a significant milestone for the neuro-interventional space as our innovation has benefited nearly 10,000 patients worldwide since the device’s launch. Thank you to all who have joined our journey. As we advance, we pledge to continue innovating for better patient outcomes.”
Disclosure: The NeVa device is currently pending U.S. clearance with the FDA and is currently not available for sale in the U.S.
References
1. Geyik S, Yoo A, Froehler MT, et al. O11/103 Primary results from the CLEAR study: safety and efficacy of the NeVa Stent Retriever for large vessel thrombectomy. Journal of NeuroInterventional Surgery 2023;15:A6-A7.
2. Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016;387:1723–31.
3. Liu Y, Gebrezgiabhier D, Reddy AS, et al. Failure modes and effects analysis of mechanical thrombectomy for stroke discovered in human brains. J Neurosurg 2022;136:197–204.
4. Machi P, Ulm AJ, Bernava G, et al. Experimental evaluation of the NeVa™ thrombectomy device a novel stent retriever conceived to improve efficacy of organized clot removal. J Neuroradiol 2019;46:163–7.
5. Ulm A, Khachatryan T, Grigorian A, Nogueira R. Preclinical evaluation of the NeVa™ stent retriever: safety and efficacy in the swine thrombectomy model. Intervent Neurol 2018;7:205–17.
6. Akpinar CK, Ozdemir AO, Gurkas E, et al. Favorable first-pass recanalization rates with NeVa thrombectomy device in acute stroke patients: Initial clinical experience. Interv Neurorad. 2020:1-7
7. Ribo M, Requena M, Macho J, et al. Mechanical thrombectomy with a novel stent retriever with multi-functional zones: initial clinical experience with the NeVaTM thrombectomy device. J Neuroradiol 2020; 47: 301–305.
8. Borggrefe J, Goertz L, Abdullayev N, et al. Mechanical thrombectomy with the novel NeVa M1 stent retriever: Do the drop zones represent a risk or benefit? World Neurosurgery 2021.
9. Bajrami A, Ertugrul O, Senadim S. et al. First pass results of mechanical thrombectomy with two-drop zone NeVaTM device. Interventional Neuroradiology 2022.
10. Zaidat OO, Castonguay AC, Linfante I, et al. First pass effect: a new measure for stroke thrombectomy devices. Stroke 2018;49:660–6.
11. Yoo A.J, Geyik S, Froehler M, et al. Primary Results from the CLEAR Study of the NeVa Stent Retriever for Large Vessel Thrombectomy. Abstract at the ISC 2023.
12. Gupta R, Saver JL, Levy E, et al. TIGER Trial Investigators. New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial. Stroke. 2021 May;52:1534-1544.
13. Zaidat OO, Bozorgchami H, Ribó M, et al. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018; 49:1107-1115.
About Vesalio
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians with superior technology designed to improve clinical outcomes. Vesalio’s proprietary NeVa™ platform is designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit vesalio.com.
The CLEAR Study has been submitted to FDA for clearance of the NeVa device, which is now pending with the FDA. The NeVa device has been available throughout Europe and other international markets for five years, where it is indicated in LVO stroke, a leading cause of death and long-term disability worldwide. Whereas endovascular clot removal has been established as the gold standard treatment for LVO stroke(2), conventional stent retriever technology has proven unsuccessful when patients present with large, hard clot varieties(3). In contrast, NeVa’s Drop Zone™ technology has been designed to extract all clot types(4,5), addressing a significant unmet clinical need for patients suffering from this life-threatening condition.
Since the NeVa launch in CE markets in 2018, several academic publications have highlighted the device’s safety and high first-pass recanalization rates(6,7,8,9), widely accepted as a consistent predictor of positive patient outcomes.10 More recently, the results of the prospective, multicenter, FDA-regulated CLEAR Study affirmed the safety and effectiveness of NeVa, which demonstrated promising first-pass rates and patient outcomes in line with previous publications(11,12,13). The CLEAR Study also showed excellent clinical outcomes, with nearly 2 out of 3 patients treated being functionally independent at 90-day follow-up. Safety results highlighted that trial participants experienced low complication rates and mortality.
"The prospective CLEAR Study confirms the value and differentiation of the NeVa device compared to other stent retrievers for achieving rapid and effective revascularization," said Prof. Dr. Serdar Geyik, who presented the results at the recent ESMINT Meeting. "The results represent a step forward for improving patient outcomes after thrombectomy."
"The results of the CLEAR Study are no surprise to stroke teams who have access to our technology in CE-accepting markets,” said Diane Tangun, VP of Market Development at Vesalio. “We want to thank physicians for recognizing the added value of NeVa and making it part of their neuro-interventional arsenal.”
Ms. Tangun also said, “The fifth anniversary of NeVa’s commercialization marks a significant milestone for the neuro-interventional space as our innovation has benefited nearly 10,000 patients worldwide since the device’s launch. Thank you to all who have joined our journey. As we advance, we pledge to continue innovating for better patient outcomes.”
Disclosure: The NeVa device is currently pending U.S. clearance with the FDA and is currently not available for sale in the U.S.
References
1. Geyik S, Yoo A, Froehler MT, et al. O11/103 Primary results from the CLEAR study: safety and efficacy of the NeVa Stent Retriever for large vessel thrombectomy. Journal of NeuroInterventional Surgery 2023;15:A6-A7.
2. Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 2016;387:1723–31.
3. Liu Y, Gebrezgiabhier D, Reddy AS, et al. Failure modes and effects analysis of mechanical thrombectomy for stroke discovered in human brains. J Neurosurg 2022;136:197–204.
4. Machi P, Ulm AJ, Bernava G, et al. Experimental evaluation of the NeVa™ thrombectomy device a novel stent retriever conceived to improve efficacy of organized clot removal. J Neuroradiol 2019;46:163–7.
5. Ulm A, Khachatryan T, Grigorian A, Nogueira R. Preclinical evaluation of the NeVa™ stent retriever: safety and efficacy in the swine thrombectomy model. Intervent Neurol 2018;7:205–17.
6. Akpinar CK, Ozdemir AO, Gurkas E, et al. Favorable first-pass recanalization rates with NeVa thrombectomy device in acute stroke patients: Initial clinical experience. Interv Neurorad. 2020:1-7
7. Ribo M, Requena M, Macho J, et al. Mechanical thrombectomy with a novel stent retriever with multi-functional zones: initial clinical experience with the NeVaTM thrombectomy device. J Neuroradiol 2020; 47: 301–305.
8. Borggrefe J, Goertz L, Abdullayev N, et al. Mechanical thrombectomy with the novel NeVa M1 stent retriever: Do the drop zones represent a risk or benefit? World Neurosurgery 2021.
9. Bajrami A, Ertugrul O, Senadim S. et al. First pass results of mechanical thrombectomy with two-drop zone NeVaTM device. Interventional Neuroradiology 2022.
10. Zaidat OO, Castonguay AC, Linfante I, et al. First pass effect: a new measure for stroke thrombectomy devices. Stroke 2018;49:660–6.
11. Yoo A.J, Geyik S, Froehler M, et al. Primary Results from the CLEAR Study of the NeVa Stent Retriever for Large Vessel Thrombectomy. Abstract at the ISC 2023.
12. Gupta R, Saver JL, Levy E, et al. TIGER Trial Investigators. New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial. Stroke. 2021 May;52:1534-1544.
13. Zaidat OO, Bozorgchami H, Ribó M, et al. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018; 49:1107-1115.
About Vesalio
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians with superior technology designed to improve clinical outcomes. Vesalio’s proprietary NeVa™ platform is designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit vesalio.com.
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Vesalio
William von Brendel
858-335-5790
www.vesalio.com
William von Brendel
858-335-5790
www.vesalio.com
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