(105 days)
No
The description focuses on the mechanical design and function of a stentriever device and does not mention any AI or ML components or capabilities.
Yes
Explanation: The device is intended to remove thrombus to restore blood flow, which is a therapeutic intervention for ischemic stroke.
No
The device is described as a revascularization device intended to restore blood flow by removing thrombus. Its design and function are purely therapeutic, not diagnostic.
No
The device description clearly outlines a physical medical device comprised of hardware components like a nitinol braided mesh, stainless steel shaft, nitinol core wire, and a handle. It is a stentriever used for mechanical thrombectomy.
Based on the provided information, the Tigertriever Revascularization Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical tool (stentriever) used to mechanically remove a clot from a blood vessel.
- Mechanism of Action: The device works by physically engaging and retrieving the thrombus from within the blood vessel.
- Lack of In Vitro Testing: The device is not used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Tigertriever device is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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.
Product codes
NRY
Device Description
The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovasculature
Indicated Patient Age Range
18-85
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Bench Tests: The device passed all performance bench testing in accordance with internal requirements, national standards, and international standards. Tests performed include simulated use test, radial force, durability, delivery, deployment and retrieval, torque strength, dimensions test, tip flexibility, kink resistance, tensile test, particulates, Austenite Finish (Af) Temperature, and coating integrity assessment.
- Biocompatibility: Based on prior testing of the Comaneci Embolization Assist Device (DEN170064), sharing manufacturing process and environment. Tests included Cytotoxicity, Irritation (Intracutaneous Reactivity), Sensitization, Hemocompatibility (Complement activation Assay, In Vitro Hemolysis), Pyrogenicity, Systemic Toxicity, and in vivo Thrombogenicity (Acute Pre-Clinical Evaluation of the Safety of Tigertriever device in a Swine Model). All tests showed acceptable results.
- Sterilization and Shelf Life: Sterilized by 100% Ethylene Oxide with a confirmed shelf life of 2.5 years.
Pre-Clinical Animal Testing Data:
- Study Type: Controlled animal study in domestic swine comparing the Tigertriever device and the predicate device.
- Sample Size: Four animals (two for acute stage - 3 days, two for chronic stage - 30 days).
- Key Results: No damage observed by angiography, no safety-related abnormalities, and comparable gross and histological findings between the subject and predicate devices. Thrombogenicity scores were comparable. The study concluded that thrombectomy using the Tigertriever was safe without evidence of vessel injuries or abnormal thrombogenicity, supporting a similar safety profile to the Solitaire predicate.
Clinical Study:
- Study Type: TIGER (Treatment with Intent to Generate Endovascular Reperfusion) clinical trial.
- Sample Size: 160 patients signed informed consent and were treated. 148 patients met all inclusion and exclusion criteria for the modified Intent-to-Treat (mITT) Cohort.
- Primary Effectiveness Endpoint: Successful revascularization defined as an mTICI score of at least 2b in the target vessel, following three or less passes of the Tigertriever device, using Core Laboratory adjudicated data.
- Primary Safety Endpoint: Composite of all-cause mortality at 90 days and/or symptomatic intracranial hemorrhage (sICH) within 24 (18-36) hours of the study procedure, adjudicated by the Clinical Events Committee (CEC).
- Key Results (mITT, N=148):
- Successful revascularization rate after Tigertriever treatment (mTICI ≥2b): 108/148 (73%). Lower Bound of 95% CI: 66.3%.
- Successful revascularization rate after first pass with Tigertriever (mTICI ≥ 2b): 81/148 (54.7%).
- Good Clinical Outcome (mRS ≤2 at 90 days): 81/148 (54.7%).
- Primary Composite Safety Endpoint (Mortality at 90 Days and/or sICH at 24 Hours post procedure): 26/147 (17.7%). Upper Bound of 95% CI: 24.8%.
- Mortality at 90 Days: 26/147 (17.7%).
- sICH at 24 Hours post procedure: 3/147 (2.0%).
- Embolization to New Territory at End of Procedure: 4/147 (2.7%).
- The TIGER study met all pre-defined success criteria, demonstrating reperfusion rates and a safety profile similar to alternative devices, supporting substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Primary Effectiveness Endpoint:
- Successful revascularization rate after Tigertriever treatment: 73% (108/148)
- Lower Bound of 95% CI: 66.3%
- Secondary Effectiveness Endpoints:
- Successful revascularization rate after first pass with Tigertriever: 54.7% (81/148)
- Good Clinical Outcome (mRS ≤2 at 90 days): 54.7% (81/148)
- Primary Composite Safety Endpoint:
- Mortality at 90 Days and/or sICH at 24 Hours post procedure: 17.7% (26/147)
- Upper Bound of 95% CI: 24.8%
- Other Safety Metrics:
- Mortality at 90 Days: 17.7% (26/147)
- sICH at 24 Hours post procedure: 2.0% (3/147)
- Total Asymptomatic ICH at 24 Hours: 31.9% (47/147)
- Neurological Deterioration at 24 Hours: 8.8% (13/147)
- Embolization to New Territory at End of Procedure: 2.7% (4/147)
Predicate Device(s)
Solitaire 2 Revascularization Device (K141491)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 23, 2021
Rapid Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K203592
Trade/Device Name: Tigertriever and Tigertriever 17 Revascularization Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 19, 2021 Received: February 19, 2021
Dear Janice Hogan:
We have reviewed vour 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/cfpmp/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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventiona1 and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203592
Device Name
Tigertriever and Tigertriever 17 Revascularization Device
Indications for Use (Describe)
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY Tigertriever Revascularization Device K203592
Submission Sponsor
Rapid Medical Ltd. Carmel Building, P.O. Box 337 Yokneam, 2069205 Israel Company Phone No .: +972-72-250-3331
Contacts:
Dr. Orit Yaniv, VP of QA/RA Email: orit@rapid-medical.com
Ronen Eckhouse, CEO Email: ronen@rapid-medical.com
Date Prepared
March 23, 2021
Device Identification
Trade/Proprietary Name: Tigertriever and Tigertriever 17 Revascularization Device Common/Usual Name: Catheter, Thrombus Retriever Classification Name: Percutaneous catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY Device Class: II Classification Panel: Neurology
Legally Marketed Predicate Device(s)
Solitaire 2 Revascularization Device (K141491)
Indication for Use Statement
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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.
4
Device Description
The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.
Comparison of Technological Characteristics with the Predicate Device
The Tigertriever and the Solitaire 2 predicate have the same indications for use, similar technological characteristics and principle of operations. Both stentrievers share similar design and similar construction materials. Both devices are used to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke. Both stentrievers are delivered to the target vessel by means of a microcatheter and expanded once deployed from the microcatheter. The expansion of the subject device is controlled by the physician, while the predicate mesh is self-expanded to a fixed diameter upon deployment. However, this difference does not raise new questions of safety or effectiveness. A detailed comparison between the Tigertriever and the predicate device is provided in the table below.
| | Tigertriever Revascularization
Device | Solitaire 2 Revascularization Device
(Predicate Device) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K203592 | K141491 |
| Regulation | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Product Code | NRY | NRY |
| | Tigertriever Revascularization
Device | Solitaire 2 Revascularization Device
(Predicate Device) |
| Indications for
Use | The Tigertriever Revascularization
Device is intended to restore blood
flow by removing thrombus from a
large intracranial vessel 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 Solitaire 2 Revascularization
Device is intended to restore blood
flow by removing thrombus from a
large intracranial vessel 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. |
| Anatomical
Location | Neurovasculature | Neurovasculature |
| Sterilization
Method | Ethylene oxide | Ethylene oxide |
| Single Use | Yes | Yes |
| Packaging | Placed into a Dispenser hoop,
blister, Tyvek pouch, and Carton
box | Placed into a Dispenser hoop, Tyvek
pouch, and Carton box |
| Distal OD
(expanded
configuration) | 3mm Tigertriever 17
6mm Tigertriever | 4mm
6mm |
| Stent length
(unexpanded
configuration) | 23mm Tigertriever 17
32mm Tigertriever | 31mm |
| Overall length | 200 cm | 184 cm |
| Design of distal
portion | Close end braided nitinol mesh,
manually expandable | Open end laser cut stent, self-
expanded |
| Mode of
operation | Manual expansion of the braided
distal portion into the clot using the
handle component | Self-expansion of the distal stent
portion into the clot following
retraction of the delivery catheter |
| Materials | | |
| Stent | Nitinol | Nitinol |
| Markers | 90% Platinum/ 10% Iridium | 90% Platinum/ 10% Iridium |
| | Tigertriever Revascularization Device | Solitaire 2 Revascularization Device (Predicate Device) |
| Core wire (shaft) | Nitinol core wire and stainless steel shaft | Nitinol wire |
| Push wire shrink tubing | PTFE | PTFE |
| Introducer Sheath | PTFE/Grilamid | PTFE |
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6
Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the device and in showing substantial equivalence to the predicate device, Rapid Medical Ltd. completed a number of non-clinical performance tests. The device meets all the requirements of overall design, sterilization, and biocompatibility. Testing results confirm that the design output meets the design specification for the device.
Biocompatibility
Biocompatibility of the Tigertriever was based on the biocompatibility testing data for the Comaneci Embolization Assist Device (DEN170064). The two devices share the same manufacturing process and same manufacturing environment. In addition, the two devices are intended to be used in the same anatomical locations, and are identical in terms of frequency and duration of exposure. Biocompatibility testing was completed for Comaneci device and consisted of the following tests: Cytotoxicity, Irritation (Intracutaneous Reactivity), Sensitization, Hemocompatibility, Pyrogenicity, Acute Systemic and Toxicity Testing. In addition, in vivo thrombogenicity was performed for the Tigertriever. Results of the biocompatibility testing indicate that Tigertriever revascularization device is biocompatible and is substantially equivalent for its intended use.
| Biological Endpoint | Test Results | Conclusion |
|---|---|---|
| Cytotoxicity - ISO | ||
| Elution Method | Grade 0 reactivity observed 48 hours | |
| post exposure to test article extract. | Non-cytotoxic | |
| Irritation - | ||
| Intracutaneous Reactivity | ||
| in Rabbit | Difference of overall mean score | |
| between test article and control was 0. | Non-irritant | |
| Sensitization - Guinea | ||
| Pig Maximization Test | Grade 0, no evidence of causing | |
| delayed dermal contact sensitization. | Does not elicit | |
| sensitization | ||
| response |
7
| Biological Endpoint | Test Results | Conclusion |
|---|---|---|
| Hemocompatibility - | ||
| Complement activation | ||
| Assay | SC5b-9 concentration of the test article | |
| sample was statistically lower than the | ||
| activated NHS control (p3 hours from symptom onset, 1 was treated with mRS 3, 2 missing pregnancy test, 1 was treated with the device over 8 hours from symptom onset, and 1 was treated with an aspiration device prior to the Tigertriever. Per FDA's request, within this mITT cohort, use of rescue therapy at any point in the procedure was imputed as a failure for the revascularization and clinical outcome endpoints. The table below summarizes the effectiveness and safety outcomes of this cohort. |
The Primary Effectiveness Endpoint was successful revascularization defined as an mTICI score of at least 2b in the target vessel, following three or less passes of the Tigertriever device, using Core Laboratory adjudicated data. The Primary Safety Endpoint defined as the composite
12
of all-cause mortality at 90 days and/or symptomatic intracranial hemorrhage (sICH) within 24 (18-36) hours of the study procedure. The Primary Safety Endpoint was adjudicated by the Clinical Events Committee (CEC).
| TIGER Study Results
| Effectiveness and Safety Results for use of only Tigertriever | |
|---|---|
| Endpoint | mITT (N=148) |
| Successful revascularization rate after Tigertriever | |
| treatment1 - | |
| Patients with mTICI ≥2b, n (%) | 108/148 (73%) |
| Lower Bound of 95% CI | 66.3% |
| Secondary Effectiveness Endpoints | |
| Successful revascularization rate after first pass with | |
| Tigertriever - patients with mTICI ≥ 2b | |
| n (%) | mITT (N=148) |
| 81 (54.7%) | |
| Good Clinical Outcome: | |
| mRS ≤2 at 90 days2 | |
| n, (%) | N= 148 |
| 81/148 (54.7%) | |
| Patient Reported Outcomes: EQ5D at 90 days3 | N= 107 |
| Mean (SD) | 73.5 (21.8) |
| Median | 80 |
| 25th to 75th | 62.5,90 |
| Patient Reported Outcomes: ALDS at 90 days3 | N= 109 |
| Mean (SD) | 11.1 (4.5) |
| Median | 13.0 |
| 25th to 75th | 8,15 |
| Primary Composite Safety Endpoint | |
| Endpoint | mITT (N=147)4 |
| Mortality at 90 Days and/or sICH at 24 Hours post | |
| procedure4 | 26 (17.7%) |
| Upper Bound of 95% CI | 24.8% |
| Mortality at 90 Days4 | 26 (17.7%) |
| sICH at 24 Hours post procedure5 | 3 (2.0%) |
| Secondary Safety Endpoints | |
| Endpoint | mITT (N=147)6 |
| Total Asymptomatic ICH at 24 Hours (%), n (%) | 47 (31.9%) |
| HI-1 | 18 (12.2%) |
| HI-2 | 12 (8.8%) |
| PH-1 | 0 |
| PH-2 | 2 (1.4%) |
| SAH | 11 (7.5%) |
| SAH and HI-2 | 2 (1.4%) |
| SAH and PH-2 | 1 (0.7%) |
| Neurological Deterioration at 24 Hours, n (%) | 13 (8.8%) |
| Embolization to New Territory at End of Procedure, n | |
| (%) | 4 (2.7%) |
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| 1 Use of rescue therapy at any point in the procedure was imputed as a failure to achieve the endpoint. |
|---|
| There were 12 cases imputed as failure. |
| 2 Five patients had missing 90 days mRS and were imputed as a failure to achieve the endpoint. |
| 3 Sample sizes vary due to missing data at 90 days. |
| 4 Reduced sample size due to one patient who withdrew consent prior to the 90 d follow up visit. |
| 5 All 3 subjects with sICH at 24 hours post-procedure died. |
| 6 Reduced sample size due to missing 24 hour CT or final angiogram. |
Definitions:
| mRS: | modified Rankin Score. |
|---|---|
| EQ5D: | EuroQol Five Dimensions. |
| ALDS: | Academic Medical Center Linear Disability Score. |
| SICH: | symptomatic Intracranial Hemorrhage, any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 points NIHSS deterioration at 24 hours. |
| HI: | Hemorrhagic Infarction. |
| PH: | Parenchymal Hematoma. |
| SAH: | Subarachnoid Hemorrhage. |
TIGER Summary of Serious Adverse Events (SAEs)
One hundred and sixty-five (165) SAE occurred within all the study population, all patients enrolled and treated with Tigertriever. The table below summarizes the frequency of the SAEs classified by System Organ.
| System Organ Class (SOC) | All
(165 Events) |
|-------------------------------------------------------------------------|---------------------|
| Blood and lymphatic system disorders | 3 (1.8%) |
| Cardiac disorders | 22 (13.3%) |
| Gastrointestinal disorders | 6 (3.6%) |
| General disorders and administration site conditions | 2 (1.2%) |
| Infections and infestations | 11 (6.7%) |
| Injury, poisoning and procedural complications | 12 (7.3%) |
| Injury, poisoning and procedural complications Vascular disorders | 1 (0.6%) |
| Investigations | 3 (1.8%) |
| Metabolism and nutrition disorders | 3 (1.8%) |
| Musculoskeletal and connective tissue disorders Psychiatric disorders | 1 (0.6%) |
| Nervous system disorders | 40 (24.2%) |
| Nervous system disorders Injury, poisoning and procedural complications | 1 (0.6%) |
| Nervous system disorders Nervous system disorders | 1 (0.6%) |
| Nervous system disorders Surgical and medical procedures | 1 (0.6%) |
| Psychiatric disorders | 1 (0.6%) |
| Renal and urinary disorders | 4 (2.4%) |
| Reproductive system and breast disorders | 1 (0.6%) |
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| System Organ Class (SOC) | All
(165 Events) |
|-------------------------------------------------|---------------------|
| Respiratory, thoracic and mediastinal disorders | 25 (15.2%) |
| Skin and subcutaneous tissue disorders | 1 (0.6%) |
| Surgical and medical procedures | 2 (1.2%) |
| Vascular disorders | 24 (14.5%) |
To conclude, the TIGER study was successfully met all pre-defined success criteria. Based on the results of this clinical study, the Tigertriever device, when used for the revascularization in ischemic stroke due to LVOs, has reperfusion rates and a safety profile similar to alternative devices. Therefore, the clinical data support the substantial equivalence.
Statement of Substantial Equivalence
The Tigertriever device has the same intended use and indications for use, and similar technological characteristics compared to the Solitaire 2 predicate device. The differences in technological characteristics between the Tigertriever and the predicate device were evaluated in bench, animal and clinical testing as discussed above and do not raise different questions regarding the safety and effectiveness and demonstrate similar performance and safety characteristics between the Tigertriever and predicate device. Therefore, the results from these tests support the conclusion that the Tigertriever device is substantially equivalent to the predicate device.