Imperative gains US FDA clearance for Zoom 88 support and announces initial cases


Imperative Care has announced US Food and Drug Administration (FDA) 510(k) clearance of its Zoom 88 large distal platform (LDP) support, a portfolio expansion of the company’s original Zoom 88 LDP.

In a press release, Imperative claims to have pioneered the use of large-bore 0.088-inch intracranial access paired with angled-tip aspiration catheters to enable better and faster reperfusion for stroke procedures. Zoom 88 support expands its 0.088-inch intracranial access portfolio—the only access portfolio on the market to enable large-bore intracranial access, the company also states.

This portfolio includes the existing Zoom 88 LDP and the Zoom RDL access platform. Additionally, the Zoom stroke solution includes four vessel-matching Zoom aspiration catheters with a unique angled tip for enhanced clot ingestion, and the powerful Zoom pump with Zoom POD for sterile-field clot capture.

Zoom 88 support features a new engineered support profile designed to maintain the capability of 0.088-inch intracranial access with added stability, giving physicians even more control over their thrombectomy procedures in a greater patient population, the Imperative release further notes.

“Zoom 88 support was purposefully designed to meet the needs of more patients and deliver on the feedback we have received from physicians,” said Ariel Sutton, general manager of Imperative’s stroke business. “Zoom 88 support provides the same benefits of intracranial access found with Zoom 88 LDP, with the ability to treat more proximal or tandem occlusions. With the introduction of Zoom 88 support, we continue to grow our patient-first portfolio to bring the benefits of large-bore intracranial access to more people.”

Alongside this, Imperative has also announced the successful completion of initial cases using Zoom 88 support. One of the first cases was performed by Harris Hawk (Erlanger Health System, Chattanooga, USA).

Zoom 88 support was used during treatment of an acute stroke in a patient with a tandem occlusion that required intracranial access with improved proximal support. In the case, Zoom 88 support provided 0.088-inch intracranial access from the femoral artery, allowing the physician to treat the distal occlusion using a Zoom aspiration catheter, in addition to providing a stable platform for treatment of the proximal occlusion, resulting in complete thrombolysis in cerebral infarction (TICI) 3 revascularisation. The patient arrived at the hospital with a debilitating National Institute of Health stroke scale (NIHSS) score of 20 and returned to a baseline score of zero the day following treatment.

“Zoom 88 support provides me with a new capability for achieving intracranial access to treat a broader population of stroke patients, enabling the best possible outcome based on each patient’s anatomy,” said Hawk. “With products like Zoom 88 support, Imperative continues to respond to the needs of patients with much-needed solutions to help streamline stroke procedures, and treat patients quickly and effectively.”


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