(212 days)
No
The device description focuses on the physical characteristics and materials of guidewires. There is no mention of software, algorithms, AI, or ML. The performance studies evaluate clinical outcomes related to the physical device's performance in procedures.
No
The device is described as a guidewire intended to introduce and position catheters and other interventional devices, which are diagnostic or procedural tools, rather than providing direct therapeutic treatment.
No
The guidewires are intended for percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, not for diagnosis.
No
The device description clearly details physical components of guidewires, including materials, dimensions, and coatings, indicating it is a hardware medical device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the guidewires are for "percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details the physical characteristics of the guidewires, such as material composition, diameter, length, coatings, and tip features. These are all consistent with devices used for navigating within blood vessels.
- Anatomical Site: The specified anatomical site is the "coronary and peripheral vasculature," which are parts of the circulatory system within the body.
- Input Imaging Modality: The mention of "fluoroscopic methods" indicates the use of real-time X-ray imaging to guide the device during the procedure within the body.
- Performance Studies: The performance studies describe clinical outcomes related to the use of the guidewires in patients during procedures (e.g., successful recanalization, MACE, perforations).
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The information provided about these guidewires does not align with the definition or typical characteristics of an IVD.
N/A
Intended Use / Indications for Use
The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occiusions (CTO).
The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
Product codes
DQX
Device Description
R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.
Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.
Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and Peripheral Vasculature
Indicated Patient Age Range
Not Found
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)
A prospective, multi-center, single-arm study of 150 subjects was performed to evaluate the safety and effectiveness of Vascular Solutions' specialized guidewires, microcatheters, and guide extensions in patients undergoing CTO-PCI. The objective of the study was to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO PCI in which at least one study guidewire and one Turnpike catheter were used.
The primary endpoint for the study was defined as procedure success through discharge or 24 hours post-procedure, whichever came first. Procedure success was defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access, and absence of in-hospital MACE (cardiac death, target lesion revascularization, or post-procedural MI defined as CK-MB >= 3x ULN). The study primary endpoint result (75.3%) met the predetermined performance goal.
Key results:
Overall Primary Endpoint Met: 75.3% (113/150)
Angiographic Visualization of any guidewire distal/proximal to CTO in the true vessel lumen: 94.7% (142/150)
Absence of in-hospital MACE: 80.7% (121/150)
Successful recanalization: 140 (93.3%)
MACE: 29 (19.3%) (In-Hospital); 0 (0.0%) (30-Day)
Clinically Significant Perforations: 16 (10.7%)
Technical Success: 140 (93.3%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Primary Endpoint Met: 75.3% (113/150)
Angiographic Visualization of any guidewire distal/proximal to CTO in the true vessel lumen: 94.7% (142/150)
Absence of in-hospital MACE: 80.7% (121/150)
Successful recanalization: 140 (93.3%)
MACE: 29 (19.3%) (In-Hospital); 0 (0.0%) (30-Day)
Clinically Significant Perforations: 16 (10.7%)
Technical Success: 140 (93.3%)
Predicate Device(s)
ASAHI Fielder XT guidewire, K171933
Reference Device(s)
R350 guidewire, K151234, Spectre guidewire, K163444, Raider guidewire, K173532, Warrior guidewire, K180128, Bandit guidewire, K181647
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2022
Vascular Solutions LLC Beka Vite Regulatory Manager 6464 Sycamore Court N Maple Grove. Minnesota 55369
Re: K212167
Trade/Device Name: R350 guidewire, Spectre guidewire, Bandit guidewire, Warrior guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II
Product Code: DQX Dated: July 9, 2021 Received: July 12, 2021
Dear Beka Vite:
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 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
1
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 Advice (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,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212167
Device Name
R350 guidewire; Spectre guidewire; Raider guidewire; Bandit guidewire; Warrior guidewire
Indications for Use (Describe)
The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occlusions (CTO).
The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | |||||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||||||
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: February 9, 2022
510(k) Number: K212167
SUBMITTER'S NAME / CONTACT PERSON
Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Beka Vite Regulatory Manager Tel: 763-656-4326
| General Information | |
|---|---|
| Trade Name | R350 guidewire |
| Spectre guidewire | |
| Raider guidewire | |
| Bandit guidewire | |
| Warrior guidewire | |
| Common / Usual Name | Catheter guidewire |
| Classification Name | 21 CFR 870.1330, DQX, Catheter guidewire, Class II |
| Predicate Device | ASAHI Fielder XT guidewire, K171933 (Asahi Intecc Co., Ltd.) |
| Reference Device | R350 guidewire, K151234 |
| Spectre guidewire, K163444 | |
| Raider guidewire, K173532 | |
| Warrior guidewire, K180128 | |
| Bandit guidewire, K181647 |
DEVICE DESCRIPTION
R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.
Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.
4
Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.
INTENDED USE
The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Warrior guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
Comparison of Technological Characteristics with the Predicate Device and Reference Device
The subject guidewires and predicate device have the same intended use, and each consist of a metallic core with a proximal PTFE and distal lubricious coating. The reference devices have the same operating principles and technological characteristics as the subject devices with the exception of length and PTFE coating supplier. The standard-length version was changed from 190 cm to 200 cm for the Spectre,
5
Raider, and Warrior guidewires, and the PTFE coating supplier was changed for the Spectre and Warrior guidewires.
A comparison of the subject and predicate device technological characteristics are provided in the following table. Questions related to clinical performance have been evaluated through design verification and validation testing, including an IDE Clinical Study.
| Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristic | Subject Guidewires | Predicate Guidewire |
| (Fielder XT - K171933) | ||
| Indications | ||
| for Use | Spectre | The Spectre guidewire is intended for use |
| in percutaneous procedures to introduce | ||
| and position catheters and other | ||
| interventional devices within the | ||
| coronary and peripheral vasculature, | ||
| including use in crossing or assisting in | ||
| crossing de novo coronary chronic total | ||
| occlusions (CTO). | ||
| Raider | The Raider guidewire is intended for use | |
| in percutaneous procedures to introduce | ||
| and position catheters and other | ||
| interventional devices within the | ||
| coronary and peripheral vasculature, | ||
| including use in crossing or assisting in | ||
| crossing de novo coronary chronic total | ||
| occlusions (CTO). | ||
| Warrior | The Warrior guidewire is intended for | |
| use in percutaneous procedures to | ||
| introduce and position catheters and | ||
| other interventional devices within the | ||
| coronary and peripheral vasculature, | ||
| including use in crossing or assisting in | ||
| crossing de novo coronary chronic total | ||
| occlusions (CTO). | ||
| Bandit | The Bandit guidewire is intended for use | |
| in percutaneous procedures to introduce | ||
| and position catheters and other | ||
| interventional devices within the | ||
| coronary and peripheral vasculature, | ||
| including use in crossing or assisting in | ||
| crossing de novo coronary chronic total | ||
| occlusions (CTO). | ||
| R350 | The R350 guidewire is intended for use in | |
| percutaneous procedures to introduce | ||
| and position catheters and other | ||
| interventional devices within the | ||
| coronary and peripheral vasculature, | ||
| including use in crossing or assisting in | ||
| crossing de novo coronary chronic total | ||
| occlusions (CTO). | ||
| Comparison of Technological Characteristics | ||
| Characteristic | Subject Guidewires | Predicate Guidewire |
| (Fielder XT - K171933) | ||
| Anatomical | ||
| Location | Spectre | Coronary and Peripheral Vasculature |
| Raider | ||
| Warrior | ||
| Bandit | ||
| R350 | ||
| Wire | ||
| Diameter | Spectre | 0.014" |
| Raider | ||
| Warrior | ||
| Bandit | ||
| R350 | 0.013" | |
| Device | ||
| Length | Spectre | 200 cm |
| 300 cm | ||
| Raider | 200 cm | |
| 300 cm | ||
| Warrior | 200 cm | |
| 300 cm | ||
| Bandit | 200 cm | |
| 300 cm | ||
| R350 | 350 cm | |
| 190 cm | ||
| 300 cm | ||
| Tip Type and | ||
| Shape | Spectre | Straight, Shapeable |
| Raider | Straight, Shapeable | |
| Warrior | Tapered, Straight, Shapeable | |
| Bandit | Tapered, Straight, Shapeable | |
| R350 | Straight | |
| Tapered, Straight | ||
| Wire | ||
| Material | ||
| (Core) | Spectre | Nitinol, Stainless Steel |
| Raider | Stainless Steel | |
| Warrior | Stainless Steel | |
| Bandit | Stainless Steel | |
| R350 | Nitinol | |
| Stainless Steel | ||
| Coating | ||
| Material | Spectre | PTFE |
| Hydrophilic | ||
| Raider | PTFE | |
| Hydrophilic | ||
| Polymer Jacket | ||
| Warrior | PTFE | |
| Hydrophilic | ||
| Bandit | PTFE | |
| Hydrophilic | ||
| Polymer Jacket | ||
| R350 | PTFE | |
| Hydrophilic | ||
| PTFE Coating | ||
| Hydrophilic Coating Over Polymer | ||
| Jacket | ||
| Tip Material | Spectre | Platinum-Tungsten, Stainless Steel |
| Raider | Platinum-Tungsten, Stainless Steel | |
| Warrior | Platinum-Tungsten, Stainless Steel | |
| Bandit | Platinum-Tungsten, Stainless Steel | |
| R350 | Gold-Coated Tungsten | |
| Platinum-Nickel | ||
| Comparison of Technological Characteristics | ||
| Characteristic | Subject Guidewires | Predicate Guidewire |
| (Fielder XT - K171933) | ||
| Sterilization | ||
| Method | Spectre | |
| Raider | ||
| Warrior | ||
| Bandit | ||
| R350 | EO |
6
7
PERFORMANCE DATA
With the exception of additional coating integrity tests and a biocompatibility assessment to evaluate the change in the PTFE coating supplier, no new biocompatibility, sterilization, packaging, shelf-life, or bench tests were performed to support the expanded indications. The existing tests performed on the reference devices, along with the clinical data described below, support the subject devices with the expanded indication.
CLINICAL DATA
A prospective, multi-center, single-arm study of 150 subjects was performed to evaluate the safety and effectiveness of Vascular Solutions' specialized guidewires, microcatheters, and guide extensions in patients undergoing CTO-PCI. The objective of the study was to evaluate angiographic confirmation of placement of any guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO PCI in which at least one study guidewire and one Turnpike catheter were used.
Device Use
A total of 566 study-guidewires (55% of the total number of guidewires used; used in all 150 subjects) and 457 non-study guidewires (45% of the total; used on 112 subjects) were used in the CTO-PCl Study. A detailed breakdown of study device wire use is provided in the following table.
| Guidewire Device Usage | |
|---|---|
| Guidewire | Number (%) of Subjects with Device Used |
| Spectre | 129 (86.0%) |
| Raider | 102 (68.0%) |
| Warrior | 35 (23.3%) |
| Bandit | 68 (45.3%) |
| R350 | 39 (26.0%) |
At least one Turnpike catheter and one study guidewire were used in all cases, and a GuideLiner catheter or TrapLiner catheter was used in all cases where a guide extension was required (64% of cases). A breakdown of Turnpike catheter use by model is provided in the following table.
| Turnpike Catheter Device Usage | |
|---|---|
| Catheter | Number (%) of Subjects with Device Used |
| Turnpike | 33 (22.0%) |
| Turnpike Spiral | 94 (62.7%) |
| Turnpike Gold | 1 (0.7%) |
8
| Turnpike Catheter Device Usage | |
|---|---|
| Catheter | Number (%) of Subjects with Device Used |
| Turnpike LP | 85 (56.7%) |
Study device procedural technique is provided in the following table.
| Procedural Technique | n (%) |
|---|---|
| Wire escalation | 86 (57.3%) |
| Dissection/re-entry | 23 (15.3%) |
| Wire externalization | 21 (14.0%) |
| Safety | 15 (10.0%) |
| Stabilization and/or support | 7 (4.7%) |
| Delivery | 5 (3.3%) |
| Reverse CART | 4 (2.7%) |
| Crossing | 2 (1.3%) |
| Not specified | 2 (1.3%) |
| CTO RCA and RPL | 1 (0.7%) |
| Donor vessel | 1 (0.7%) |
| Knuckled | 1 (0.7%) |
| Workhorse | 1 (0.7%) |
Primary Endpoint
The primary endpoint for the study was defined as procedure success through discharge or 24 hours post-procedure, whichever came first. Procedure success was defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access, and absence of in-hospital MACE (cardiac death, target lesion revascularization, or post-procedural MI defined as CK-MB ≥ 3x ULN).
Summary of Primary Endpoint Analysis
The study primary endpoint result (75.3%) met the predetermined performance goal.
| Category | Study Results
% (n/N) |
|------------------------------------------------------------------------------------------------|--------------------------|
| Overall Primary Endpoint Met | 75.3% (113/150) |
| Components of Primary Endpoint | |
| Angiographic Visualization of any guidewire distal/proximal to
CTO in the true vessel lumen | 94.7% (142/150) |
| Absence of in-hospital MACE | 80.7% (121/150) |
9
Secondary Endpoint
The secondary endpoints include:
- Frequency of successful recanalization (defined as angiographic confirmation of crossing CTO and restoring blood flow to the affected area).
- Frequency of MACE through discharge or 24 hours post-procedure, whichever comes first (inhospital follow-up), and at 30 days post-procedure (MACE components are also reported separately).
- Frequency of clinically significant perforation (defined as any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy).
- Procedural success according to crossing technique.
- Technical success.
Summary of Secondary Endpoint Analysis
| Parameter | Study Results
% (n/N) |
|-----------------------------------------|--------------------------|
| Successful recanalization | 140 (93.3%) |
| MACE | 29 (19.3%) |
| In-Hospital | 29 (19.3%) |
| 30-Day | 0 (0.0%) |
| Clinically Significant Perforations | 16 (10.7%) |
| Procedure Success by Crossing Technique | |
| Antegrade | 69 (85.2%) (69/81) |
| Retrograde | 1 (50.0%) (1/2) |
| Combined Antegrade and Retrograde | 43 (64.2%) (43/67) |
| Technical Success | 140 (93.3%) |
MACE includes all MIs defined as CK-MB ≥ 3x ULN.
In a multicenter, prospective registration trial, procedural success was achieved in a high lesion complexity patient population (e.g. 94.7% severely calcified lesions) using contemporary technique and application of dedicated CTO guidewires, microcatheters and guide catheter extensions. No new safety or effectiveness issues were raised during the study. These results demonstrate that the subject guidewires are suitable for their intended use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The clinical data raised no new questions of safety and effectiveness compared to the predicate devices, supporting that the subject guidewires with the expanded indication are substantially equivalent to the predicate devices.
CONCLUSION
The Spectre, Raider, Warrior, Bandit, and R350 guidewires are substantially equivalent to the predicate device.