(370 days)
QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.
The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.
Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.
| Metric/Study Objective | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Pre-Clinical Swine Model | ||
| Efficacy in Coumadin-treated pigs | Effective control of bleeding | 94.5% successful control of bleeding (vs 24% for control gauze) |
| Efficacy in Plavix-treated pigs | Effective control of bleeding | 91.2% successful control of bleeding (vs 29.7% for control gauze) |
| Safety in animal model | Safe use in anticoagulated model | No animal deaths due to bleeding. Wounds not fully controlled required additional manual compression. |
| Trabattoni D, et al. (2010) - Single Arm Pilot Study | ||
| Complete bleeding cessation at 5 min | High rate of cessation | Mean cumulative hemostasis time 4.9 ± 1.05 min (diagnostic: 4.2 ± 0.9 min, interventional: 5.3 ± 0.95 min) |
| Safe ambulation at 4 hours | All patients achieve safe ambulation | All patients achieved ambulation at 4 hours |
| Serious Adverse Events | Low incidence of adverse events | One patient required extra compression and developed a small hematoma (< 5cm) |
| Trabattoni D, et al. (2011) - Randomized Controlled Trial | ||
| Hemostasis time vs. manual compression | Shorter hemostasis time | QuikClot: 5.4 ± 1.5 min vs. Manual Compression: 25 ± 15 min (p<0.001) |
| Hemostasis failure rate | No hemostasis failure | No hemostasis failure in either group |
| Major bleeding / Hematoma > 5cm | Low incidence of events | Major Bleeding: 1 pt (QuikClot) vs. 1 pt (control); Hematoma > 5cm: 1 pt (QuikClot) vs. 2 pts (control) |
| Politi L, et al. (2011) - Randomized Clinical Trial (Radial) | ||
| Radial Artery Occlusion (RAO) | Low to no RAO | Group 1 (QuikClot): 0% RAO; Group 2 (control short time): 5% RAO; Group 3 (control 2 hours): 10% RAO (p = 0.05) |
| Active bleeding after compression removal | Lower incidence than control | Group 1 (QuikClot): 10 patients (20%); Group 2 (control short time): 18 patients (90%); Group 3 (control 2 hours): 1 patient (2%) (p < 0.001) |
| Post-Market Data | ||
| Success rate in controlling bleeding | High success rate | 96% success rate |
| Reported complications | Low incidence of complications | 1% reported complications |
| User satisfaction | High satisfaction | 93% improved outcome, 95% saved time, 97.4% would use again |
2. Sample Sizes and Data Provenance
-
Pre-clinical Study (Swine Model):
- Sample Size: 10 pigs (5 treated with Plavix, 5 with Coumadin). 187 intra-abdominal vascular injuries were tested across these animals.
- Data Provenance: United States (US), prospective animal model study.
-
Trabattoni D, et al. (2010):
- Sample Size: 40 human subjects.
- Data Provenance: Outside US (OUS), prospective single-arm pilot trial.
-
Trabattoni D, et al. (2011):
- Sample Size: 200 human subjects (100 in QuikClot group, 100 in manual compression control group).
- Data Provenance: Outside US (OUS), prospective randomized controlled trial.
-
Politi L, et al. (2011):
- Sample Size: 120 human subjects (Group 1 (QuikClot) n=50; Group 2 (control short time) n=20; Group 3 (control 2 hours) n=50). The study stopped enrolling Group 2 subjects due to unethically high bleeding rates.
- Data Provenance: Outside US (OUS), randomized clinical trial.
-
Post-Market Data:
- Sample Size: 138 Product Evaluation Forms. (Number of patients not explicitly stated, but implies at least 138 instances of use).
- Data Provenance: United States (US), real-world usage reports (retrospective collection of feedback forms).
3. Number of Experts and Qualifications for Ground Truth
- Animal Study: "One investigator" from a US site. Specific qualifications (e.g., veterinarian, surgeon) are not detailed. The ground truth (success/failure of bleeding cessation) was based on direct observation.
- Clinical Studies (Trabattoni and Politi): These were peer-reviewed clinical publications. The "ground truth" for outcomes like bleeding cessation, hemostasis time, ambulation, and adverse events would have been established by the study investigators (physicians/clinicians) based on direct observation, medical records, and established clinical protocols.
- Trabattoni (2010): Three investigators from one OUS site.
- Trabattoni (2011): Six investigators from one OUS site.
- Politi (2011): Ten investigators from one OUS site.
- Specific qualifications of these investigators (e.g., interventional cardiologist, years of experience) are not provided in this document, but being published implies they were qualified medical professionals.
- Post-Market Data: The "ground truth" for success/failure and complications was based on reports from "several health care institutions in the US." These would be the observations and assessments of the healthcare professionals using the device. Specific qualifications or number of individual experts are not given for this aggregated data.
4. Adjudication Method for the Test Set
The provided summary does not detail explicit adjudication methods for events or outcomes in the clinical studies (e.g., an independent clinical events committee). For the animal study, the single investigator would have determined success/failure. For the human studies, the study endpoints and assessment protocols would have guided the determination of outcomes by the investigators. It does not mention complex multi-reader/adjudicator processes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not explicitly mentioned. The clinical studies (Trabattoni (2011) and Politi (2011)) were randomized controlled trials comparing the device to standard care (manual compression), but they do not appear to be structured as MRMC studies that typically evaluate reader performance on cases with and without AI assistance. The studies here compare device performance (QuikClot) against a traditional method (manual compression) from the perspective of patient outcomes.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The QuikClot Interventional-A Hemostatic Bandage is a physical medical device (hemostatic dressing), not an algorithm or AI. Its performance is intrinsically linked to its application by a human healthcare professional as an adjunct to manual compression. The studies assess the device's effectiveness when used by humans.
7. Type of Ground Truth Used
- Pre-clinical Animal Study: Direct observation of bleeding cessation in a live animal model (surgical wounds).
- Clinical Studies (Trabattoni and Politi): Clinical observations, measurements (hemostasis time, ambulation time), and documented adverse events by medical investigators. This aligns with clinical outcomes data and expert assessment.
- Post-Market Data: Real-world clinical outcomes and observations reported by healthcare professionals through product evaluation forms.
8. Sample Size for the Training Set
The provided document describes the QuikClot Interventional-A Hemostatic Bandage as a modified version of a previously cleared device (K090620), with the primary change being an expanded indication for use in anticoagulated patients. The device itself is a physical product (kaolin-impregnated gauze), not a machine learning model. Therefore, the concept of a "training set" for an algorithm doesn't apply directly.
The device's development and prior clearance (K090620 and K072474) would have involved earlier testing and validation. The studies described in this K120782 submission serve as the test set to demonstrate the safety and effectiveness of the device for the new indication (use in anticoagulated patients).
If we interpret "training set" loosely as the accumulated evidence that informs the device's design and previous clearances:
- The device's core technology (kaolin hemostatic properties) is based on fundamental scientific principles and earlier research not detailed here.
- The original QuikClot Hemostatic Dressings (K072474) and QuikClot Interventional Hemostatic Bandage (K090620) underwent their own performance testing, which would form a "training set" of evidence for the device's general efficacy before this specific extended indication.
Relevant "Training" (Prior Evidence) mentioned:
The specific sample sizes for these prior clearances are not provided in the K120782 document.
9. How the Ground Truth for the Training Set Was Established
As explained above, since this is a physical medical device and not an AI algorithm, the concept of establishing ground truth for a "training set" in the machine learning sense doesn't apply. Instead, the prior evidence supporting the initial clearance of the QuikClot Interventional Hemostatic Bandage (K090620) and its predecessors (K072474) would have involved:
- Non-clinical (Bench and Animal) Testing: Biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, repeat exposure systemic toxicity), likely following ISO standards. These would have established the safety profile and basic hemostatic function.
- Clinical Data: The original submissions would have included clinical data to demonstrate the device's effectiveness for its initial indications. This would involve clinical observations, measurements, and adverse event reporting, similar to how ground truth was established for the "test set" studies presented in K120782.
The K120782 document focuses on adding a new indication to an already cleared and proven device. The studies presented within K120782 specifically address the safety and efficacy of the device (with its existing technology and design) when used in the new patient population (anticoagulated patients).
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April 21, 2023
Z-Medica Corporation Sheila Wallin, RT, CRA Vice President of Clinical and Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K120782
Trade/Device Name: QuikClot Interventional-A Hemostatic Bandage Regulatory Class: Unclassified Product Code: QSY
Dear Sheila Wallin, RT, CRA:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 20, 2013. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Z-Medica, Corporation % Ms. Sheila Wallin, RT, CRA Vice President of Clinical and Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
March 20, 2013
Re: K120782
Trade/Device Name: QuikClot Interventional-A Hemostatic Bandage Regulatory Class: Unclassified Product Code: FRO Dated: January 25, 2013 Received: February 01, 2013
Dear Ms. Wallin:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device.as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Ms. Sheila Wallin, RT, CRA
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, FOR
Peter ₪燕Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120782
Device Name: QuikClot Interventional-A Hemostatic Bandage
Indications for Use:
QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JiyoungDang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120782
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1. SUBMITTER/510(K) HOLDER
Z-Medica. LLC 4 Fairfield Blvd. Wallingford, CT 06492 Contact Person: Sheila K Wallin 203-294-0000 x 308 Telephone: Date Prepared: March 4, 2013
. MAR 2 0 2013
2. DEVICE NAME
Proprietary Name: QuikClot Interventional-A Hemostatic Bandage Common/Usual Name: Hemostatic Dressing Classification Name: Wound Dressing
3. PREDICATE DEVICES
- K060409 HemoHalt Hemostasis Pad Wound Dressing .
- K112961 Scion Cardio-Vascular Clo-Sur PLUS .
- K040208 TZ Medical Neptune Pad and Comfort Band(Interventional and Radial) .
- K090620 QuikClot Interventional Dressings .
4. DEVICE DESCRIPTION
The purpose of this 510(k) is to obtain a new indication for the previously cleared QuikClot Interventional Hemostatic Bandage subject of K090620. The new indication to be added to the previously cleared device is simply for compatibility with Therefore, the proposed indications for use are as follows: anticoagulant therapy. QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment. QuikClot Interventional-A Hemostatic Bandage has been tested in clinical trials and its efficacy has been shown only in patients treated with the anti-coagulation medications: heparin, Clopidrogel bisulfate and warfarin. The efficacy of QuikClot Interventional-A Hemostatic Bandage in the presence of other anti-coagulation medications is not known. QuikClot Interventional-A Hemostatic Bandage has not been tested on patients with bleeding disorders due to underlying disease (liver, kidney or others) and is not indicated for these populations. This 510(k) was not submitted as a Special 510(k) Premarket Notification because a new indication has been added to the previously cleared indications for the QuikClot Interventional Hemostatic Bandage.
The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic
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dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.
ട്. INTENDED USE
QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The QuikClot Interventional-A Hemostatic Bandage is substantially equivalent to the predicate devices with respect to device characteristics and intended use.
The QuikClot Interventional-A Hemostatic Bandage contains a hemostatic agent, kaolin. The formulation of the proposed and predicate QuikClot device is identical and the only modification is in the intended use and indications for use. The QuikClot Interventional-A Hemostatic Bandage and the predicate devices are equivalent in that they all contain a hemostatic agent that functions to stop bleeding in anticoagulated patients.
7. PERFORMANCE TESTING
Biocompatibility and performance testing have been included which supports the substantial equivalence of the proposed QuikClot Interventional-A Hemostatic Bandage. Specifically, the following testing has been performed to support K090620 and the original QuikClot Hemostatic Dressings subject of K072474:
| Cytotoxicity | L929 Neutral Red Uptake according to ISO 10993-5:2009'Biological Evaluation of Medical Devices, Part 5: Tests for InVitro Cytotoxicity' | Non-cytotoxic |
|---|---|---|
| Irritation | ISO 10993-10:2002, Amendment 1:2006, 'Biological Evaluationof Medical Devices, Part 10; Tests for Irritation and Delayed-TypeHypersensitivity' | Non-irritating |
| Sensitization | ISO 10993-10:2002, Amendment 1:2006, 'Biological Evaluationof Medical Devices, Part 10; Tests for Irritation and Delayed-TypeHypersensitivity' | Non-sensitizing |
| SystemicInjection(intraperitoneal) | International Organization for Standardization 10993: BiologicalEvaluation of Medical Devices, Part 11: Tests for SystemicToxicity (ISO). | Non-toxic |
| SystemicInjection(intravenousinjection) | International Organization for Standardization 10993: BiologicalEvaluation of Medical Devices, Part 11: Tests for SystemicToxicity (ISO). | Non-toxic |
| Genotoxicity | ISO 10993-3:2003 Biological evaluation of medical devices Part3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Non-mutagenic |
| Repeat ExposureSystemicToxicity | Custom Designed Test Program | Non-toxic |
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8. SAFETY AND EFFICACY
Animal testing has been performed to demonstrate compatibility of the QuikClot Hemostatic Dressing and anticoagulant therapy. This testing showed that the QuikClot Hemostatic Dressing is used safely and effectively in the swine animal model on drug/induced anticoagulant therapy.
| TABLE | 1 |
|---|---|
| ------- | --- |
| Study Name/Description | Pre-clinical evaluation of QuikClot in a swine model of anti-coagulation | |||
|---|---|---|---|---|
| Objective | To evaluate the efficacy of Kaolin, the active ingredient in Z-Medica's QuikClot Combat Gauze in controlling bleeding inanimals treated with common drugs such as Coumadin andPlavix. | |||
| Number of sites/investigators(OUS/US) | One site (US) and one investigator | |||
| Number of animals | Ten pigs were divided in 2 groups (five animals each): | |||
| Number of wounds | One group received Plavix at 75 mg/day orally for > 5 days. Thesecond group received daily doses of Coumadin until INR was >3. | |||
| 187 intra-abdominal vascular injuries (splenic, liver andmesenteric) were tested. Injuries consisted of surgically inflictedwounds with mixed arterial and venous bleeding. The size of thewounds was 5cm in length and 3-5 mm in depth for liver andspleen, and 2 mm of depth for the mesentery. | ||||
| Procedure | In combination with manual pressure, QuikClot was applied to aseries of wounds at the level of the liver, spleen, mesentery andfemoral artery and compared to standard surgical gauze. Thestudy was prospective, open label, randomized 1:1 betweenQuikClot and control. | |||
| Manual compression was applied over the wounds for 5 minutesand then released. | ||||
| Success/Failure criteria | Success = 100% complete bleeding cessation within 5 minutesFailure = persistent bleeding at 5 minutes | |||
| Study results | Animals treated with Coumadin and QuikClot showed successfulcontrol of bleeding in 94.5% of wounds. Animals treated withCoumadin and control gauze showed control of bleeding in 24%. | |||
| Animals treated with Plavix and QuikClot showed successfulcontrol of bleeding in 91.2% of wounds. Animals treated withPlavix and control gauze showed control of bleeding in 29.7% ofwounds%. | ||||
| QuikClot Combat Gauze versus Control in Coumadin treatedPigs (n=5) | ||||
| Pass | Fail | Total | ||
| Test | 52 | 3 p<0.001 | 55 | |
| Control | 9 | 29 p<0.001 | 38 | |
| 93 | ||||
| QuikClot Combat Gauze versus Control in Plavix treated Pigs(n=5) | ||||
| Pass | Fail | Total | ||
| Test | 52 | 5 p<0.001 | 57 |
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| Control | 11 | 26 p<0.001 | 37 | |
|---|---|---|---|---|
| 94 | ||||
| Adverse events | No animals died because of bleeding. The wounds whereQuikClot did not control bleeding completely within 5 minutesrequired some additional manual compression time. |
Additional Clinical Data/References:
Several peer reviewed clinical publications support the use of QuikClot Interventional Hemostatic Bandage in human patients on drug/induced anticoagulant therapy.
| œ | ) | ||
|---|---|---|---|
| Study Name/Description | Trabattoni D, et al. A New Kaolin-based Hemostatic BandageUse after Percutaneous Coronary Diagnostic andInterventional Procedures; Internat J Cardiol; 2010 Nov 172. | ||
|---|---|---|---|
| Number of sites/investigators(OUS/US) | One site (OUS). Three investigators | ||
| Number of subjects | 40 subjects | ||
| Inclusion/ | Patients undergoing diagnostic angiography or percutaneouscoronary intervention via a femoral artery approach | ||
| Exclusion | Not described in publication | ||
| Procedure | Prospective single arm pilot trial of QuikClot InterventionalHemostatic Bandage in cardiac catheterization.Introducer sheath size 6 Fr (90%) or 7 Fr (10%)Femoral artery sheath removed once the ACT $<$ 180 secondsAll patients were treated with QuikClot InterventionalHemostatic bandage after arterial sheath removal | ||
| Study endpoints and assessmentprotocol | Complete 100% bleeding cessation at 5 minutes and safeambulation at 4 hours | ||
| Duration of follow-up | 30 days | ||
| Patient Demographics | 75% maleMean Age = 68+/- 11 years | ||
| Patient condition (means ofachieving anticoagulation, level ofanticoagulation) | Patient undergoing diagnostic angiogram (62%) vs. PercutaneousCoronary Intervention PCI (38%) via femoral artery approach 6F(90%) 7F (10%). | ||
| QuikClot n=40 | |||
| LMW Heparin | 2.5% | ||
| Aspirin + Clopidogrel | 27.5% | ||
| Aspirin | 60% | ||
| Aspirin + Warfarin | 5% | ||
| IV Heparin | 38% | ||
| No anticoagulation | 5% | ||
| Study results | Mean ACT value at hemostasis 138 + 24 seconds (range 95-186seconds) | ||
| Mean cumulative hemostasis time 4.9±1.05 min | |||
| • Diagnostic procedures 4.2±0.9 min | |||
| • Interventional procedures 5.3±0.95 min | |||
| Ambulation time 4 h for all patients | |||
| Adverse events | One PCI patient required extra compression time to achievehemostasis and developed a small (< 5cm) hematoma |
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| TABLE 3 | |||
|---|---|---|---|
| Study Name/Description | Trabattoni D, et al. A New Kaolin-based HaemostaticBandage Compared with Manual Compression for BleedingControl after Percutaneous Coronary Procedures; Eur Radiol,2011 Aug 21(8): 1687-91. | ||
| Number of sites/investigators(OUS/US) | One site (OUS), six investigators | ||
| Number of subjects | 200 subjectsProspective randomized trial of QuikClot(n=100) vs. manualcompression (n=100) | ||
| Inclusion/ | Undergoing angiography or percutaneous coronary interventionvia a femoral approach | ||
| Exclusion | Patients with baseline INR > 1.4 excludedPatients who had previous arterial access at the same femoral sitewithin 30 days excluded | ||
| Procedure | Femoral arterial sheath removed once the ACT $\le$ 180 secondsPatients randomized to receive QCI gauze or manual compressionafter femoral sheath removal | ||
| Patient ambulation at 4 hours. | |||
| Study endpoints and assessmentprotocol | Complete 100% bleeding cessation at 5 minutes and safeambulation at 4 hours | ||
| Duration of follow-up | 30 days | ||
| Patient demographics | Male 70% QuikClot vs. 60% ControlMean age (years) 65.7±13 vs. 73.6±6.2Weight (Kg) 73.9±12 vs. 71.2±15Diagnostic procedure (n=98) vs. Percutaneous coronaryintervention (n=102) | ||
| Patient condition (means ofachieving anticoagulation, level ofanticoagulation) | Introducer sheath size 6 Fr (90%) or 7 Fr (10%) | ||
| QuikClot | Control | ||
| LMW Heparin | 4% | 2% | |
| Aspirin +Clopidogrel | 29% | 26% | |
| Aspirin | 60% | 60% | |
| Aspirin +Warfarin | 7% | 3% | |
| IV Heparin | 51% | 49% | |
| No anticoagulation | 0% | 9% | |
| Study results | Mean ACT value at hemostasis 146 + 24 seconds (range 98 - 198seconds)Hemostasis with QCI bandage = 5.4 ± 1.5 minHemostasis with manual compression = 25 ± 15 min p<0.001No hemostasis failure in either group | ||
| Adverse events | Major Bleeding: 1 patient in each groupHaematoma, > 5 cm1* pt (QuikClot) vs. 2 pts (control)Pseudoaneurysm1* pt (QuikClot) vs. 1 pt (control) |
.
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| TABLE 4 | ||||
|---|---|---|---|---|
| Study Name/Description | Politi L, et al. Randomized Clinical Trial on Short-Time Compression with Kaolin Filled Pad: A New Strategy to Avoid Early Bleeding and Subacute Radial Artery Occlusion after Percutaneous Coronary Intervention; J Internat Card; 2011; Vol 24; 65-72 | |||
| Objective | To evaluate the occurrence of 24 hour radial artery occlusion and the rate of bleeding of a novel hemostatic device for radial closure after percutaneous interventions, in adjunct to short-time compression. | |||
| Number of sites/investigators (OUS/US) | One site (OUS). Ten investigators | |||
| Number of subjects | 120 subjects divided in 3 groups:Group 1 (QuikClot n=50)Group 2 (control short time - 15 minute compression n=20)Group 3 (control 2 hours compression time n=50) | |||
| Inclusion/ | All patients undergoing transradial elective diagnostic or interventional coronary procedures between November 1, 2009 and January 31, 2010 | |||
| Exclusion | Abnormal Allen's test before punctureFailure to provide written informed consent | |||
| Procedure | QuikClot was applied to the radial artery over the sheath which was then removed. Pressure was maintained for 15 minutes and then completely relaxed. | |||
| Study endpoints and assessment protocol | The main end-point was subacute Radial Artery Occlusion (RAO)The secondary end-point was failure of the closure technique (death, MI or major bleeding occurring in hospital)Groups 1 and 2: 15 minute assessment for bleedingGroup 3: 2 hour assessment for bleedingAll groups: Radial artery patency assessed at 24 hours using Barbeau's Test | |||
| Duration of follow-up | Until patient discharge and follow-up visit. Follow-up at 6 months was done for patients who developed RAO | |||
| Patient demographics | Age (years) Group 1 = $64.16 \pm 11.53$ , Group 2 = $61.30 \pm 14.22$ , Group 3 = $59.72 \pm 14.23$ (p=N/S)Male 37 (74%), 14 (70%), 36 (72%) (p=N/S)Weight (kg) $76.42 \pm 11.13$ , $80.00 \pm 14.96$ , $82.02 \pm 13.26$ (p=N/S) | |||
| Patient condition (means of achieving anticoagulation, level of anticoagulation) | QuikClot | Control Group 1 | Control Group 2 | |
| Aspirin | 46 (92%) | 19 (95%) | 50 (100%) | |
| Clopidogrel | 10 (20%) | 2 (10%) | 11 (22%) | |
| LMW Heparin | 8 (16%) | 5 (25%) | 5 (10%) | |
| Warfarin | 6 (12%) | 5 (25%) | 5 (10%) | |
| IV heparin | 100% | 100% | 100% | |
| No anticoagulation | 0% | 0% | 0% | |
| Several patients received multiple therapies | ||||
| Randomization Assignment | Based on computer generated randomization list patient received one of the three treatment groups below:Group 1: Compression of radial artery using QuikClot Interventional hemostatic pad with folded gauze over the pad and taped for 15 minutes; Compression dressing then removed |
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| leaving the QuikClot pad which was secured using Tegadermdressing for 2 hours. | |
|---|---|
| Group 2: Compression of radial artery using folded gauze whichwas taped for 15 minutes; Compression dressing was thenremoved leaving the sterile gauze which was secured usingTegaderm dressing for 2 hours | |
| Group 3: Direct compression of the site of puncture with a foldedsterile gauze wrapped with tape and maintained for 2 hours | |
| Study results | While a total of 150 patients were planned to be enrolled, thestudy stopped enrolling group 2 subjects after the 20th patient dueto unethically high rates of bleeding. |
| Radial Artery OcclusionNone of the patients enrolled in Group 1(QuikClot) developedRAO the main outcome variable.Among patients enrolled in Group 2 RAO occurred in 1 case(5%) and among Group 3 in 5 cases (10%) (p = 0.05) | |
| Adverse events | Active bleeding after compression removal |
| Group 1: 10 patients (20%)Group 2: 18 (90%)Group 3: 1 (2%) (p < 0.001) | |
| In all cases, hemostasis was achieved with a supplementarycompression for 2 hours that did not produced any RAO in Group1 |
Post Market Data:
One hundred and thirty-eight Product Evaluation Forms were received from several health care institutions in the US where the QuikClot products were used for patients who were on anticoagulant medications. Seventy one percent of the patients were on anticoagulants. The QuikClot Dressings demonstrated a 96% success rate in controlling bleeding in treated subjects within the expected amount of time. There was a 4% rate of reported residual oozing which required additional manual compression time and 1% reported complications which are commonly reported for Interventional procedures. Ninety-three % of respondents indicated that QuikClot Interventional improved the outcome of their procedures and 95% reported that QuikClot products saved them time. A total of 97.4% of users would use QuikClot products again. Only 2 adverse events were reported and they were both in non-anticoagulant evaluations. One was reported as a small hematoma and the other was described as requiring 6 minutes to achieve hemostasis instead of 5 minutes.
9. CONCLUSION
Z-Medica believes that based on the indications for use, technological characteristics, and comparison with predicate devices the QuikClot Interventional-A Hemostatic Bandage has been shown to be substantially equivalent and is safe and effective for its intended use for patients on drug/induced anti-coagulation treatment utilizing heparin, Clopidrogel bisulfate or warfarin.
N/A