Trevo XP ProVue Retriever

K190779 · Stryker · POL · Jun 25, 2019 · Neurology

Device Facts

• Record ID: K190779
• Device Name: Trevo XP ProVue Retriever
• Applicant: Stryker
• Product Code: POL · Neurology
• Decision Date: Jun 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Device Story

Trevo XP ProVue Retriever is a neurovascular mechanical thrombectomy device used to restore blood flow by removing thrombi in acute ischemic stroke patients. The device consists of a flexible, tapered nitinol core wire with a shaped distal section and platinum markers for fluoroscopic visualization. It features a hydrophilic coating to reduce friction. The device is delivered to the thrombus site via a microcatheter. Once deployed, the retriever captures the thrombus; the device is then retracted, optionally using an aspiration catheter and pump (e.g., AXS Universal Aspiration System) to assist in clot removal. The procedure is performed by a physician in a clinical setting. The device is supplied sterile for single use. By facilitating mechanical clot removal, the device aims to restore cerebral perfusion and reduce patient disability.

Clinical Evidence

Evidence includes an analysis of Real World Data (RWD) from the Trevo Retriever Registry and a comprehensive review of clinical literature. The data supports the safety and effectiveness of the combination approach using the Trevo Retriever with intermediate catheter aspiration. Simulated use bench testing in a 37°C neurovascular model confirmed the device's ability to retrieve clots and achieve recanalization, meeting all acceptance criteria.

Technological Characteristics

Core wire: Nitinol; Shaped section: Nitinol; Distal coil: Platinum/Tungsten; Proximal coil: 304 Stainless Steel; Solder: Gold/Tin; Coating: Sodium hyaluronate mixture. Device is a flexible, tapered core wire with a shaped distal section. Sterilization: 100% EtO. Connectivity: None. Form factor: 180-190cm length, 0.015-0.018 inch core diameter.

Indications for Use

Indicated for patients with acute ischemic stroke, including those with persistent, proximal anterior circulation large vessel occlusions (ICA or MCA-M1) and smaller core infarcts. Applicable to patients within 6-24 hours of symptom onset/last seen well, including those ineligible for or failing IV t-PA therapy.

Regulatory Classification

Identification

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

Special Controls

In combination with the general controls of the FD&C Act, the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including: (i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces. (ii) Mechanical testing to evaluate the radial forces exerted by the device. (iii) Non-clinical testing to verify the dimensions of the device. (iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions. (v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized. (vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions. (vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions. (3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device. (4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life. (5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure. (6) The labeling must include: (i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size. (ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature. (iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events. (iv) A shelf life.

Predicate Devices

• Trevo XP ProVue Retriever (K173352)

Reference Devices

• Trevo Retriever (K120961)

Submission Summary (Full Text)

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June 25, 2019

Stryker Neurovascular Rhoda M. Santos Senior Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K190779

Trade/Device Name: Trevo XP ProVue Retriever Regulation Number: 21 CFR 882.5600 Regulation Name: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment Regulatory Class: Class II Product Code: POL, NRY Dated: March 26, 2019 Received: March 27, 2019

Dear Rhoda M. Santos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190779

Device Name Trevo XP ProVue Retriever

#### Indications for Use (Describe)

1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.

2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within

6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

| Type of Use (Select one or both, as applicable) | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="margin-right:5px;"> <td>Prescription Use (Part 21 CFR 801 Subpart D)</td> <td><div style="display:flex; align-items:center;"><span style="margin-right:5px;"></span></div></td> <td>Over-The-Counter Use (21 CFR 801 Subpart C)</td> </span></div> | Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:flex; align-items:center;"><span style="margin-right:5px;"></span></div> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Trade Name: | Trevo XP ProVue Retriever |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Trevo Retrievers |
| Classification Name: | - Neurovascular Mechanical Thrombectomy Device for Acute<br>Ischemic Stroke Treatment, 21 CFR 882.5600, Class II<br>- Percutaneous Catheter, 21CFR 870.1250, Class II |
| Product Code: | POL, NRY |
| Submitter: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538<br>Tel [phone]<br>Fax [phone]<br>Facility Registration #3008853977 |
| Contact: | Rhoda M. Santos<br>Senior Principal Regulatory Affairs Specialist |
| Date Prepared: | March 26, 2019 |
| Primary Predicate Device: | Trevo XP ProVue Retriever (K173352) |
| Reference Predicate<br>Device: | Trevo Retriever (K120961) |

#### Device Description

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever has a hydrophilic coating to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device is provided with the Retriever to facilitate manipulation and retrieval. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining the Guide Wire Extension to the Retriever facilitates removal or exchange of a catheter while maintaining the Retriever position in anatomy. After the exchange has been completed, the extension can be detached.

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#### Accessories

The Retriever is provided with two accessories: a torque device which facilitates manipulation of the Retriever, and an insertion tool that is used to introduce the Retriever into a Microcatheter.

#### Indications for Use

The Indications for Use are as follows:

- 1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
- 2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
- 3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation. large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

#### Technological Characteristics and Product Feature Comparison

The Trevo XP ProVue Retriever subject devices are identical to the Primary Predicate and Reference Predicate devices and differ only by the modifications to the Instructions for Use (IFU). The technological characteristics and principles of operation remain unchanged except for the alternate use of an aspiration catheter with an aspiration pump. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility, bench-top data, sterilization and stability data from the Primary Predicate device (K173352) and Reference Predicate device (K120961) are directly applicable.

Table 1 below provides a comparison between the Subject, the Primary Predicate and Reference Predicate devices.

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| Feature | Reference Predicate Device<br>Trevo ProVue Retriever<br>(K120961) | Primary Predicate Device<br>Trevo ProVue Retriever and Trevo XP<br>ProVue Retriever (K173352) | Subject Device<br>Trevo XP ProVue Retriever<br>with Modified DFU | Rationale for<br>Modification (if<br>applicable) |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Trevo Retriever is intended to<br>restore blood flow in the<br>neurovasculature by removing<br>thrombus in patients experiencing<br>ischemic stroke within 8 hours of<br>symptom onset. Patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV-tPA) or<br>who fail IV t-PA therapy are<br>candidates for treatment. | Neurovascular mechanical<br>thrombectomy device for acute ischemic<br>stroke treatment used in the treatment of<br>acute ischemic stroke to improve clinical<br>outcomes. | Same as predicate K173352. | Not applicable. |
| Indications for Use | The Trevo Retriever is intended to<br>restore blood flow in the<br>neurovasculature by removing<br>thrombus in patients experiencing<br>ischemic stroke within 8 hours of<br>symptom onset. Patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV-tPA) or<br>who fail IV t-PA therapy are<br>candidates for treatment. | 1. The Trevo Retriever is indicated for<br>use to restore blood flow in the<br>neurovasculature by removing<br>thrombus for the treatment of acute<br>ischemic stroke to reduce disability in<br>patients with a persistent, proximal<br>anterior circulation, large vessel<br>occlusion, and smaller core infarcts<br>who have first received intravenous<br>tissue plasminogen activator (IV t-<br>PA). Endovascular therapy with the<br>device should start within 6 hours of<br>symptom onset.<br>2. The Trevo Retriever is intended to<br>restore blood flow in the<br>neurovasculature by removing<br>thrombus in patients experiencing<br>ischemic stroke within 8 hours of<br>symptom onset. Patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy are<br>candidates for treatment.<br>3. The Trevo Retriever is indicated for<br>use to restore blood flow in the | Same as predicate K173352. | Not applicable. |
| Feature | Reference Predicate Device<br>Trevo ProVue Retriever<br>(K120961) | Primary Predicate Device<br>Trevo ProVue Retriever and Trevo XP<br>ProVue Retriever (K173352) | Subject Device<br>Trevo XP ProVue Retriever<br>with Modified DFU | Rationale for<br>Modification (if<br>applicable) |
| | | neurovasculature by removing<br>thrombus for the treatment of acute<br>ischemic stroke to reduce disability in<br>patients with a persistent, proximal<br>anterior circulation, large vessel<br>occlusion of the internal carotid artery<br>(ICA) or middle cerebral artery<br>(MCA)-M1 segments with smaller<br>core infarcts (0-50 cc for age < 80<br>years, 0-20 cc for age ≥ 80 years).<br>Endovascular therapy with the device<br>should start within 6-24 hours of time<br>last seen well in patients who are<br>ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or<br>who fail IV t-PA therapy. | | |
| REGULATORY INFORMATION | | | | |
| Regulation Number/<br>Name/ Class/ Product<br>Code | 21 CFR 870.1250, Percutaneous<br>Catheter, Class II, NRY | 21 CFR 882.5600 / Neurovascular<br>Mechanical Thrombectomy Device for<br>Acute Ischemic Stroke Treatment, Class<br>II, POL<br>21 CFR 870.1250, Percutaneous Catheter,<br>Class II, NRY | Same as predicate K173352. | Not applicable. |
| | | | | |
| Target Population | Patients experiencing acute ischemic stroke | | Same as predicate K173352<br>and K120961. | Not applicable. |
| Anatomical Sites | Neurovasculature | | Same as predicate K173352<br>and K120961. | Not applicable. |
| TECHNOLOGICAL CHARACTERISTICS | | | | |
| Feature | Reference Predicate Device | Primary Predicate Device | Subject Device | Rationale for |
| | Trevo ProVue Retriever | Trevo ProVue Retriever and Trevo XP | Trevo XP ProVue Retriever | Modification (if |
| | (K120961) | ProVue Retriever (K173352) | with Modified DFU | applicable) |
| Device Description | The Retriever consists of a flexible,<br>tapered core wire with a shaped<br>section at the distal end. A platinum<br>coil allows fluoroscopic<br>visualization. The Retriever has a<br>hydrophilic coating to reduce<br>friction. The Retriever has a shaft<br>marker to indicate proximity of<br>Retriever tip relative to<br>Microcatheter tip. A torque device<br>and insertion tool are provided with<br>the Retriever. | The Retriever consists of a flexible,<br>tapered core wire with a shaped section at<br>the distal end. Platinum markers at the<br>distal end allow fluoroscopic<br>visualization. In addition, the shaped<br>section is also radiopaque. Retriever<br>dimensions are indicated on product label.<br>The Retriever has a hydrophilic coating to<br>reduce friction during use. The Retriever<br>has a shaft marker to indicate proximity<br>of Retriever tip relative to Microcatheter<br>tip. A torque device is provided with the<br>Retriever to facilitate manipulation. The<br>torque device is used to lock the core wire<br>to the microcatheter during the procedure.<br>Locking of the torque device to the wire<br>allows the microcatheter and Retriever to<br>be retracted as a system during clot<br>retrieval. An insertion tool is provided to<br>introduce the Retriever into a<br>Microcatheter. The Insertion Tool is a<br>sheath in which the Retriever comes<br>preloaded. Once half the retriever's length<br>is inserted into the microcatheter, the<br>insertion tool is removed. Retrievers have<br>a modified proximal end that permits<br>attachment of the Abbott Vascular DOC<br>Guide Wire Extension (REF 22260).<br>Joining Guide Wire Extension to<br>Retriever facilitates removal or exchange<br>of a catheter while maintaining Retriever<br>position in anatomy. After exchange has<br>been completed, the extension can be<br>detached. | The Retriever consists of a<br>flexible, tapered core wire with<br>a shaped section at the distal<br>end. Platinum markers at the<br>distal end allow fluoroscopic<br>visualization. In addition, the<br>shaped section is also<br>radiopaque. Retriever<br>dimensions are indicated on<br>product label. The Retriever has<br>a hydrophilic coating to reduce<br>friction during use. The<br>Retriever has a shaft marker to<br>indicate proximity of Retriever<br>tip relative to Microcatheter tip.<br>A torque device is provided<br>with the Retriever to facilitate<br>manipulation and retrieval. An<br>insertion tool is provided to<br>introduce the Retriever into a<br>Microcatheter. The Insertion<br>Tool is a sheath in which the<br>Retriever comes preloaded.<br>Once half the retriever's length<br>is inserted into the<br>microcatheter, the insertion tool<br>is removed. Retrievers have a<br>modified proximal end that<br>permits attachment of the<br>Abbott Vascular DOC Guide<br>Wire Extension (REF 22260).<br>Joining Guide Wire Extension<br>to Retriever facilitates removal<br>or exchange of a catheter while<br>maintaining Retriever position<br>in anatomy. After exchange has<br>been completed, the extension<br>can be detached. | Clarification for use<br>of Retriever. |
| Feature | Reference Predicate Device<br>Trevo ProVue Retriever<br>(K120961) | Primary Predicate Device<br>Trevo ProVue Retriever and Trevo XP<br>ProVue Retriever (K173352) | Subject Device<br>Trevo XP ProVue Retriever<br>with Modified DFU | Rationale for<br>Modification (if<br>applicable) |
| Principle of<br>Operation | The Trevo Retriever is delivered to the thrombus using a Microcatheter. The<br>Microcatheter is then retracted to deploy the shaped section of the Retriever. The<br>Retriever and Microcatheter are pulled back to capture the thrombus. The<br>Retriever, thrombus and Microcatheter are then removed from the body. | The Trevo Retriever is delivered to the thrombus using a Microcatheter. The<br>Microcatheter is then retracted to deploy the shaped section of the Retriever. The<br>Retriever and Microcatheter are pulled back to capture the thrombus. The<br>Retriever, thrombus and Microcatheter are then removed from the body. | The Trevo Retriever is delivered<br>to the thrombus using a<br>Microcatheter. The<br>Microcatheter is then retracted<br>to deploy the shaped section of<br>the Retriever. If using an<br>Aspiration Catheter, remove<br>Microcatheter. Advance<br>Aspiration Catheter over<br>proximal section of Retriever<br>while applying aspiration using<br>a 60 mL syringe or an aspiration<br>pump. The Retriever with<br>Microcatheter or Aspiration<br>Catheter are pulled back to<br>capture the thrombus. The<br>Retriever, thrombus, and<br>Microcatheter or Aspiration<br>Catheter are removed as a unit<br>from the body. | Revised to reflect<br>alternative use of<br>Aspiration Catheter<br>with an aspiration<br>pump. Bench<br>testing, clinical<br>data, and a review<br>of relevant clinical<br>literature<br>demonstrates the<br>alternative<br>aspiration source<br>does not raise new<br>issues of safety or<br>effectiveness. |
| Procedural Steps<br>Aspiration Source | Syringe | | Aspiration pump | Bench testing,<br>clinical data, and a<br>review of relevant clinical literature<br>demonstrates the<br>alternative<br>aspiration source<br>does not raise new<br>issues of safety or<br>effectiveness. |
| Sizes | 4x20mm…