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The Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.

Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

Device Description

The Imperative Care Zoom System consists of the following devices:

Zoom Catheters
- o Zoom™ (71, 55, 45, 35) Catheters
Large Distal Platform Catheters (LDP Catheters) ●
- Zoom™ 88 Large Distal Platform™ (Zoom 88 LDP) o
- Zoom™ 88 Large Distal Platform™ Support (Zoom 88 LDP Support) O
- TracStar™ LDP Large Distal Platform™ (TracStar LDP) O
Zoom Aspiration Tubing and Zoom POD Aspiration Tubing
Zoom Aspiration Pump ●

The Zoom Catheters and the LDP Catheters are intended to be used as a system in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and the Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus in patients with acute ischemic stroke.

The Zoom Catheters and LDP Catheters are single lumen, braid and coil reinforced, variable stiffness catheters with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The catheters have a luer hub on the proximal end.

Dimensions for each catheter are included on the individual device label. The Zoom Catheters are compatible with 0.014" - 0.018" guidewires. The LDP Catheters are compatible with 0.038" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 45, 55, and 71 Catheters are compatible with 6F guide sheaths with a minimum inner diameter of 0.088". The Zoom 35 Catheter is compatible with 5F guide sheaths with a minimum inner diameter of 0.068". The LDP Catheters are compatible with 8F or greater introducer sheaths with a minimum inner diameter of 0.115". The Zoom 71 Catheter is compatible with 5F microcatheters or intermediate catheters with a maximum outer diameter of 0.065". The Zoom 45 and 55 Catheters are compatible with 2.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.031". The Zoom 35 Catheter is compatible with 1.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.018". The LDP Catheters are compatible with 6F microcatheters or intermediate catheters with a maximum outer diameter of 0.083".

All catheters are packaged with an accessory rotating hemostasis valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices.

The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom Catheter and the LDP Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD Aspiration Tubing are made of common medical grade polymers.

In addition to the accessories discussed above, the adjunctive devices and supplies listed below could be used with the Zoom System.

Guidewires
Support/Diagnostic Catheters
Introducer Sheaths
Aspiration Pump*
- Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg)
- 0 Airflow rating of 0 23 LPM
- 0 IEC 60601-1 Compliant

Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Imperative Care Zoom System, based on the provided text:

Acceptance Criteria and Device Performance

The study refers to "performance goals" but does not explicitly define each as an "acceptance criterion" with a specific threshold prior to reporting results. Based on the way the results are presented against these goals, they are treated as acceptance criteria. Performance goals were met for effectiveness and a specific safety endpoint.

Acceptance Criteria (Performance Goal as stated in the text)	Reported Device Performance
Effectiveness: Lower bound of the two-sided 95% CI > 69% for mTICI ≥ 2b in three or fewer passes of Zoom System without using other devices.	84% (177/211; 95% CI: 78% to 89%)
Safety: Observed rate 69%. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH), observed in 0.9% (95% CI: 0.1%-3.4%), meeting the performance goal of

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K Number

K961193

Device Name

FULL FRAME ZOOM SYSTEM

Manufacturer

XRE CORP.

Date Cleared

1996-06-17

(88 days)

Product Code