INTERVENTIONAL HEMOSTATIC BANDAGE
Device Facts
| Record ID | K120782 |
|---|---|
| Device Name | INTERVENTIONAL HEMOSTATIC BANDAGE |
| Applicant | Z-Medica Corporation |
| Product Code | QSY · SU |
| Decision Date | Mar 20, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
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.
Device Story
Hemostatic bandage consisting of kaolin-impregnated gauze; applied topically as adjunct to manual compression. Used in clinical settings (e.g., cardiac catheterization labs) by healthcare providers to manage surface bleeding at vascular access sites. Kaolin acts as hemostatic agent to accelerate clotting in patients on anti-coagulation therapy. Device may be provided in kit form with adhesive bandage (e.g., 3M Tegaderm). Output is physical hemostasis; assists clinicians in achieving faster bleeding control compared to manual compression alone; reduces time to ambulation; improves procedural efficiency.
Clinical Evidence
Evidence includes pre-clinical swine model study (n=10) and three human clinical trials. Swine study showed 94.5% (Coumadin) and 91.2% (Plavix) bleeding control success vs. 24-29% for control gauze (p<0.001). Human trials (n=40, n=200, n=120) demonstrated effective hemostasis in patients on anti-coagulation therapy (heparin, clopidogrel, warfarin). Trials showed significantly reduced hemostasis time compared to manual compression (e.g., 5.4 min vs 25 min, p<0.001) and reduced radial artery occlusion rates.
Technological Characteristics
Soft, white, kaolin-impregnated gauze; multi-layer pad (1.5" x 1.5" x 0.5"). Hemostatic principle: kaolin-induced coagulation. Biocompatibility per ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity). Non-electronic, standalone dressing.
Indications for Use
Indicated for local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes (up to 7 Fr.) in patients on drug-induced anti-coagulation treatment (specifically heparin, clopidogrel bisulfate, or warfarin). Not indicated for patients with bleeding disorders due to underlying disease (e.g., liver, kidney).
Regulatory Classification
Identification
To temporarily control bleeding and cover external wounds.
Predicate Devices
- HemoHalt Hemostasis Pad Wound Dressing (K060409)
- Scion Cardio-Vascular Clo-Sur PLUS (K112961)
- TZ Medical Neptune Pad and Comfort Band (K040208)
- QuikClot Interventional Dressings (K090620)
Reference Devices
- 3M Tegaderm bandage (K973036)
- QuikClot Hemostatic Dressings (K072474)
Related Devices
- K090620 — QUIKCLOT INTEVENTIONAL, MODEL P/N 182 · Z-Medica Corporation · Apr 8, 2009
- K181641 — QuikClot Radial · Z-Medica, LLC · Dec 24, 2018
- K123387 — QUIKCLOT HEMOSTATIC DRESSING · Z-Medica, LLC · Apr 12, 2013
- K021062 — CHITO-SEAL · Abbott Vascular, Inc. · Aug 23, 2002
- K040118 — VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC · Vascular Solutions, Inc. · Feb 12, 2004
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and full name on the right. The Department of Health and Human Services seal is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text to the right of the square.
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
{1}------------------------------------------------
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.
{2}------------------------------------------------
### 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
{3}------------------------------------------------
# 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
{4}------------------------------------------------
#### 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
{5}------------------------------------------------
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<br>'Biological Evaluation of Medical Devices, Part 5: Tests for In<br>Vitro Cytotoxicity' | Non-cytotoxic |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Irritation | ISO 10993-10:2002, Amendment 1:2006, 'Biological Evaluation<br>of Medical Devices, Part 10; Tests for Irritation and Delayed-Type<br>Hypersensitivity' | Non-irritating |
| Sensitization | ISO 10993-10:2002, Amendment 1:2006, 'Biological Evaluation<br>of Medical Devices, Part 10; Tests for Irritation and Delayed-Type<br>Hypersensitivity' | Non-sensitizing |
| Systemic<br>Injection<br>(intraperitoneal) | International Organization for Standardization 10993: Biological<br>Evaluation of Medical Devices, Part 11: Tests for Systemic<br>Toxicity (ISO). | Non-toxic |
| Systemic<br>Injection<br>(intravenous<br>injection) | International Organization for Standardization 10993: Biological<br>Evaluation of Medical Devices, Part 11: Tests for Systemic<br>Toxicity (ISO). | Non-toxic |
| Genotoxicity | ISO 10993-3:2003 Biological evaluation of medical devices Part<br>3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Non-mutagenic |
| Repeat Exposure<br>Systemic<br>Toxicity | Custom Designed Test Program | Non-toxic |
{6}------------------------------------------------
### 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-<br>coagulation | | | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------------|-------|
| Objective | To evaluate the efficacy of Kaolin, the active ingredient in Z-<br>Medica's QuikClot Combat Gauze in controlling bleeding in<br>animals treated with common drugs such as Coumadin and<br>Plavix. | | | |
| Number of sites/investigators<br>(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. The<br>second group received daily doses of Coumadin until INR was ><br>3. | | | |
| | 187 intra-abdominal vascular injuries (splenic, liver and<br>mesenteric) were tested. Injuries consisted of surgically inflicted<br>wounds with mixed arterial and venous bleeding. The size of the<br>wounds was 5cm in length and 3-5 mm in depth for liver and<br>spleen, and 2 mm of depth for the mesentery. | | | |
| Procedure | In combination with manual pressure, QuikClot was applied to a<br>series of wounds at the level of the liver, spleen, mesentery and<br>femoral artery and compared to standard surgical gauze. The<br>study was prospective, open label, randomized 1:1 between<br>QuikClot and control. | | | |
| | Manual compression was applied over the wounds for 5 minutes<br>and then released. | | | |
| Success/Failure criteria | Success = 100% complete bleeding cessation within 5 minutes<br>Failure = persistent bleeding at 5 minutes | | | |
| Study results | Animals treated with Coumadin and QuikClot showed successful<br>control of bleeding in 94.5% of wounds. Animals treated with<br>Coumadin and control gauze showed control of bleeding in 24%. | | | |
| | Animals treated with Plavix and QuikClot showed successful<br>control of bleeding in 91.2% of wounds. Animals treated with<br>Plavix and control gauze showed control of bleeding in 29.7% of<br>wounds%. | | | |
| | QuikClot Combat Gauze versus Control in Coumadin treated<br>Pigs (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<br>(n=5) | | | |
| | | Pass | Fail | Total |
| | Test | 52 | 5 p<0.001 | 57 |
{7}------------------------------------------------
| | Control | 11 | 26 p<0.001 | 37 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------------|----|
| | | | | 94 |
| Adverse events | No animals died because of bleeding. The wounds where<br>QuikClot did not control bleeding completely within 5 minutes<br>required 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 Bandage<br>Use after Percutaneous Coronary Diagnostic and<br>Interventional Procedures; Internat J Cardiol; 2010 Nov 172. | | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|
| Number of sites/investigators<br>(OUS/US) | One site (OUS). Three investigators | | |
| Number of subjects | 40 subjects | | |
| Inclusion/ | Patients undergoing diagnostic angiography or percutaneous<br>coronary intervention via a femoral artery approach | | |
| Exclusion | Not described in publication | | |
| Procedure | Prospective single arm pilot trial of QuikClot Interventional<br>Hemostatic Bandage in cardiac catheterization.<br>Introducer sheath size 6 Fr (90%) or 7 Fr (10%)<br>Femoral artery sheath removed once the ACT $<$ 180 seconds<br>All patients were treated with QuikClot Interventional<br>Hemostatic bandage after arterial sheath removal | | |
| Study endpoints and assessment<br>protocol | Complete 100% bleeding cessation at 5 minutes and safe<br>ambulation at 4 hours | | |
| Duration of follow-up | 30 days | | |
| Patient Demographics | 75% male<br>Mean Age = 68+/- 11 years | | |
| Patient condition (means of<br>achieving anticoagulation, level of<br>anticoagulation) | Patient undergoing diagnostic angiogram (62%) vs. Percutaneous<br>Coronary Intervention PCI (38%) via femoral artery approach 6F<br>(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 95-186<br>seconds) | | |
| | 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 achieve<br>hemostasis and developed a small (< 5cm) hematoma | | |
{8}------------------------------------------------
| TABLE 3 | | | |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------|
| Study Name/Description | Trabattoni D, et al. A New Kaolin-based Haemostatic<br>Bandage Compared with Manual Compression for Bleeding<br>Control after Percutaneous Coronary Procedures; Eur Radiol,<br>2011 Aug 21(8): 1687-91. | | |
| Number of sites/investigators<br>(OUS/US) | One site (OUS), six investigators | | |
| Number of subjects | 200 subjects<br>Prospective randomized trial of QuikClot(n=100) vs. manual<br>compression (n=100) | | |
| Inclusion/ | Undergoing angiography or percutaneous coronary intervention<br>via a femoral approach | | |
| Exclusion | Patients with baseline INR > 1.4 excluded<br>Patients who had previous arterial access at the same femoral site<br>within 30 days excluded | | |
| Procedure | Femoral arterial sheath removed once the ACT $\le$ 180 seconds<br>Patients randomized to receive QCI gauze or manual compression<br>after femoral sheath removal | | |
| | Patient ambulation at 4 hours. | | |
| Study endpoints and assessment<br>protocol | Complete 100% bleeding cessation at 5 minutes and safe<br>ambulation at 4 hours | | |
| Duration of follow-up | 30 days | | |
| Patient demographics | Male 70% QuikClot vs. 60% Control<br>Mean age (years) 65.7±13 vs. 73.6±6.2<br>Weight (Kg) 73.9±12 vs. 71.2±15<br>Diagnostic procedure (n=98) vs. Percutaneous coronary<br>intervention (n=102) | | |
| Patient condition (means of<br>achieving anticoagulation, level of<br>anticoagulation) | Introducer sheath size 6 Fr (90%) or 7 Fr (10%) | | |
| | QuikClot | | Control |
| | LMW Heparin | 4% | 2% |
| | Aspirin +<br>Clopidogrel | 29% | 26% |
| | Aspirin | 60% | 60% |
| | Aspirin +<br>Warfarin | 7% | 3% |
| | IV Heparin | 51% | 49% |
| | No anticoagulation | 0% | 9% |
| Study results | Mean ACT value at hemostasis 146 + 24 seconds (range 98 - 198<br>seconds)<br>Hemostasis with QCI bandage = 5.4 ± 1.5 min<br>Hemostasis with manual compression = 25 ± 15 min p<0.001<br>No hemostasis failure in either group | | |
| Adverse events | Major Bleeding: 1 patient in each group<br>Haematoma, > 5 cm<br>1* pt (QuikClot) vs. 2 pts (control)<br>Pseudoaneurysm<br>1* pt (QuikClot) vs. 1 pt (control) | | |
.
{9}------------------------------------------------
| TABLE 4 | | | | |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-----------------|-----------------|
| Study Name/Description | Politi L, et al. <i>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</i> | | | |
| 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:<br>Group 1 (QuikClot n=50)<br>Group 2 (control short time - 15 minute compression n=20)<br>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 puncture<br>Failure 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)<br>The secondary end-point was failure of the closure technique (death, MI or major bleeding occurring in hospital)<br>Groups 1 and 2: 15 minute assessment for bleeding<br>Group 3: 2 hour assessment for bleeding<br>All 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)<br>Male 37 (74%), 14 (70%), 36 (72%) (p=N/S)<br>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:<br>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 | | | |
.
{10}------------------------------------------------
| | leaving the QuikClot pad which was secured using Tegaderm<br>dressing for 2 hours. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Group 2: Compression of radial artery using folded gauze which<br>was taped for 15 minutes; Compression dressing was then<br>removed leaving the sterile gauze which was secured using<br>Tegaderm dressing for 2 hours |
| | Group 3: Direct compression of the site of puncture with a folded<br>sterile gauze wrapped with tape and maintained for 2 hours |
| Study results | While a total of 150 patients were planned to be enrolled, the<br>study stopped enrolling group 2 subjects after the 20th patient due<br>to unethically high rates of bleeding. |
| | Radial Artery Occlusion<br>None of the patients enrolled in Group 1(QuikClot) developed<br>RAO the main outcome variable.<br>Among patients enrolled in Group 2 RAO occurred in 1 case<br>(5%) and among Group 3 in 5 cases (10%) (p = 0.05) |
| Adverse events | Active bleeding after compression removal |
| | Group 1: 10 patients (20%)<br>Group 2: 18 (90%)<br>Group 3: 1 (2%) (p < 0.001) |
| | In all cases, hemostasis was achieved with a supplementary<br>compression for 2 hours that did not produced any RAO in Group<br>1 |
### 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.
