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ClotTriever XL catheter for large blood vessels, i.e., inferior vena ceva on FDA Recall

Reporter: Aviva Lev-Ari, PhD, RN

The ClotTriever XL catheter, like Inari Medical’s other ClotTriever devices, was designed to treat deep vein thrombosis. Marketed as “a large device for the largest vein,” it was built specifically to target issues found in the vena cava.

The clinical advantage of the ClotTriever system

The CLOUT registry (NCT03575364) is a prospective, single-arm study evaluating outcomes of all-comer patients with proximal lower extremity DVT after thrombectomy with the ClotTriever system. CLOUT enrolled 500 patients from 43 US clinical sites. In-hospital results demonstrated safe and effective thrombus removal with immediate symptom relief. https://www.inarimedical.com/clottriever-system

“Operation of a thrombectomy catheter may cause embolization of some thrombus and/or thrombotic particulate, physician discretion advised,” according to another new warning. “The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when ClotTriever XL catheter is used to engage and remove thrombus from large vessels such as the inferior vena cava.”

The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.

Inari Medical has published updated instructions for use (IFU) that include additional warnings.

For example, the new IFU tell users to avoid pulling the ClotTriever XL “caudal to cranial” through upper extremity access or jugular vein access. In addition, users should ensure the device is “slowly retracted distally away from the heart” while still tracking sheath position and visualization under fluoroscopy.

SOURCE for Clinical Trials on the device

1. Dexter D, Kado H, Shaikh A, et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. J Soc Cardiovasc Angiog Interv. 2023;2(2):100585.
2. Shaikh A, et al. Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: analysis from the 500-patient CLOUT registry. Cardiovasc Intervent Radiol. 2023; 46(11):1571-1580.

SOURCE for FDA Recall

https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/fda-announces-recall-inari-medical-catheter-after-6-deaths-4-injuries?utm_source=newsletter&utm_medium=cvb_news