Jay Geller

Food and Drug Administration Approves Panoply of Medical Devices, Issues Slew of Regulatory Actions

On August 15, 2015, the Food and Drug Administration (FDA) approved the Orbera Intragastric Balloon from Apollo Endosurgery, Inc, Austin, TX 78746, for use as an adjunct to weight reduction for adults with obesity with a body mass index of 30 kg/m or greater and 40 kg/m or lower and for use in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise, and behavior modification programs. The maximum placement period for ORBERA is 6 months. On August 18, 2015, the FDA approved the Hymovis from Fidia Farmaceutici, SpA, Brookline, MA 02446, for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics (eg, acetaminophen). On September 1, 2015, the FDA approved the Augment Bone Graft from Biomimetic Therapeutics, LLC, Franklin, TN 37067, for use as an alternative to autograft in arthrodesis (ie, surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination) due to OA, posttraumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence, indicating the need for supplemental graft material. On September 2, 2015, the FDA approved the GenVisc 850 from OrthogenRx, Incorporated, New Hope, PA 18938, for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, for example, acetaminophen. On September 8, 2015, the FDA approved the t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM from Tandem Diabetes Care, Inc, San Diego, CA 92121, for the t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM (Bt:slim G4 System[). This device consists of the t:slim G4 Insulin Pump paired with the Dexcom G4 Platinum Sensor and Transmitter. The t:slim G4 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim G4 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim G4 System to receive and display continuous glucose measurements from the Dexcom G4 Platinum Sensor and Transmitter. The t:slim G4 System also includes continuous glucose monitoring (CGM) indicated for detecting trends and tracking patterns in persons with diabetes for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The t:slim G4 System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim G4 System results should be based on the trends and patterns seen with several sequential readings over time. The t:slim G4 System is indicated for use in individuals 12 years or older. The t:slim G4 System is intended for single patient use and requires a prescription. On September 15, 2015, the FDA approved the Zenith Alpha Thoracic Endovascular Graft from Cook Medical Incorporated, Bloomington, IN 47402, for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair, including (1) iliac/femoral anatomy that is suitable for access with the required introduction systems and (2) nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: (a) with a length of at least 20 mm and (b) with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm. On October 2, 2015, the FDA approved the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Corresponding author: Jay Geller, JD, MBA, 12100 Wilshire Blvd, Suite 1250, Los Angeles, CA 20025. The author declares no conflicts of interest. DOI: 10.1097/JCE.0000000000000150 Washington Scene

The Food and Drug Administration Approves a Multitude of Medical Device Products

On April 1, 2016, the Food and Drug Administration (FDA) approved the Heartlight Endoscopic Ablation System from Cadrdiofus, Inc, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. On April 6, 2016, FDA approved the Medtronic Micra Transcatheter Pacemaker System from Medtronic, Inc, for use in patients who have experienced one or more of the following conditions: symptomatic paroxysmal or permanent high-grade AV block in the presence of atrial fibrilliation (AF) symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual-chamber pacing, when atrial lead placement is considered difficult or high risk or not deemed necessary for effective therapy and symptomatic bradycardiatachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual-chamber pacing, when atrial lead placement is considered difficult or high risk or not deemed necessary for effective therapy. Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity. On April 11, 2016, FDA approved the Vysis chronic lymphocytic leukemia (CLL) fluorescence in situ hybridization (FISH) Probe Kit from Abbott Molecular, Inc. This is a test to detect deletion of the LSI TP53 probe target via FISH in peripheral blood specimens from patients with B-cell CLL. The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA (venetoclax) is indicated. The Vysis CLL FISH Probe Kit is not intended for the monitoring of residual disease. Also on April 11, 2016, FDA approved the Tridyne Vascular Sealant from Neomend, Inc, for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage. On April 12, 2016, FDA approved the Epi proColon from Epigenomic S AG. This test is a qualitative in vitro diagnostic test for the detection of methylated septin 9 DNA in EDTA plasma derived from patient whole-blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC). The test uses a real-time polymerase chain reaction with a fluorescent hydrolysis probe for the methylation-specific detection of the septin 9 DNA target. The Epi proColon test is indicated to screen adults of either sex, 50 years or older, defined as an average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined before offering the Epi proColon test. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results should be used in combination with the physician’s assessment and individual risk factors in guiding patient management. On April 25, 2016, FDA approved the ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead from Boston Scientific for the treatment of the following conditions: (1) symptomatic paroxysmal or permanent secondor third-degree AV block, (2) symptomatic bilateral bundle branch block, (3) symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (ie, sinus bradycardia, sinus arrest, sinoatrial block), (4) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, and (5) neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from the maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of the following: (1) conduction disorders that require restoration of AV synchrony, including varying degrees of AV block; (2) VVI intolerance (ie, pacemaker syndrome) in the presence of persistent sinus rhythm; and (3) low cardiac output or congestive heart failure secondary to bradycardia. Passive-fixation Washington Scene

FDA Approves Variety of Medical Devices

On December 19, 2014, the Food and Drug Administration (FDA) approved the premarket approval application (PMA) for BRACAnalysis CDx, an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole-blood specimens collected in EDTA. Single-nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex polymerase chain reaction. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108. Myriad Genetic Laboratories is the holder of the PMA. On November 25, 2014, FDA approved the Animas Vibe System, which consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas Vibe Insulin Pump is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the Animas Vibe System to receive and display continuous glucose measurements from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas Vibe System’s continuous glucose monitoring is indicated for detecting trends and tracking patterns in persons (aged Q18 years) with diabetes and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. Continuous glucose monitoring aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G4 PLATINUM Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The system is intended for single patient use and requires a prescription. The PMA holder is Animas Corporation (200 Lawrence Dr, West Chester, PA 19380). On November 14, 2014, FDA notified Ideal Implant Incorporated (5005 LBJ Freeway, Suite 900, Dallas, TX 75244) that it approved the PMA for the company’s IDEAL IMPLANT, a saline-filled breast implant. This device is indicated for women at least 18 years old undergoing primary breast augmentation to increase breast size or revision breast augmentation to correct or improve the result of a primary breast augmentation surgery. Expiration dating for this device has been established and approved at 3 years. On October 24, 2014, FDA approved the TactiCath Quartz Catheter and TactiSysQuartz Equipment. This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and 3-dimensional mapping system. The PMA was submitted by St Jude Medical (One St Jude Medical Drive, St Paul, MN 55117). On October 9, 2014, FDA approved the PMA for Lutonix 035 Drug Coated Balloon PTA Catheter from Lutonix, Inc (9409 Science Center Dr, New Hope, MN 55428). This device is indicated for percutaneous transluminal angioplasty, after predilatation, of de novo or restenotic lesions up to 150 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4 to 6 mm. On October 22, 2014, FDA announced the classification of Nucleic AcidYBased Devices for the Detection of Mycobacterium tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The agency classified the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device. These devices are intended to aid in the diagnosis of pulmonary tuberculosis and the selection of an initial treatment regimen when used in conjunction with clinical findings and other laboratory results. These devices do not provide confirmation of antibiotic susceptibility because other mechanisms of resistance may exist that may be associated with a lack of clinical response to treatment other than those detected by the device. Washington Scene

FDA Publishes Draft Guidance on Substantial Equivalence

On July 15, 2014, the Food and Drug Administration (FDA) published a draft guidance titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] With Different Technological Characteristics. A submitter of a premarket notification submission (often referred to as a 510(k)) must demonstrate to the FDA in its 510(k) submission that the new device is ‘‘substantially equivalent’’ (SE) to a legally marketed (predicate) device. At certain points in the substantial equivalence analysis, the probable benefits and risks of a new device as compared with a predicate device may be relevant. The benefit-risk factors discussed in this guidance may assist FDA reviewers in making substantial equivalence determinations and may help accommodate evolving technology during the 510(k) premarket process. This guidance may also help submitters of 510(k) premarket notifications demonstrate substantial equivalence in their premarket submissions. FDA has developed this guidance in order to improve the predictability, consistency, and transparency of the 510(k) premarket review process. This guidance does not change the 510(k) premarket review standard or create extra burden on a submitter of a 510(k) to provide additional performance data from what has traditionally been submitted during the review process for 510(k) submissions.

FDA Approves Panoply of New Devices, Issues Important New Guidance Documents

The Food and Drug Administration (FDA) recently approved the VASCADE Vascular Closure System from Cardiva Medical, Inc, Sunnyvale, California, for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5F, 6F, or 7F procedural sheath. The VASCADE Vascular Closure System is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5F, 6F, or 7F procedural sheath. Another device approved is the MarginProbe System from Dune Medical Devices, Inc, Philadelphia, Pennsylvania, as an adjunctive diagnostic tool for identification of cancerous tissue at the margins (e1 mm) of the main ex vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer. Another device recently approved is the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410FM, 410FF, 410MM, and 410MF) from Allergan, Goleta, California, for women for the following uses (procedures): (1) breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery; and (2) breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed because of cancer or trauma or that has failed to develop properly because of a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. Finally, another device recently approved is the Aorfix AAA Flexible Stent Graft System from Lombard Medical, Westwood, Massachusetts, for the treatment of patients with abdominal aortic and aortoiliac aneurysms having vascular morphology suitable for endovascular repair, including (1) adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories; (2) aortic neck landing zone diameters with a range of 19 to 29 mm; (3) nonaneurysmal proximal neck center-line length of l5 mm or greater; (4) infrarenal aortic neck angulations including those up to and including 90 degrees; (5) common iliac landing zone diameters with a range of 9 to 19 mm; and (6) distal fixation length of 15 mm or greater.

Food and Drug Administration Issues Key Guidance on Heparin

On June 25, 2013, the Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled ‘‘Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.’’ This guidance was initially published on February 13, 2012, as draft guidance. The draft was revised to clarify FDA’s expectations and recommendations and to include references to a recently developed assay for detecting ruminant contamination of crude heparin. This guidance provides recommendations that will help active pharmaceutical ingredient manufacturers, pharmaceutical and medical device manufacturers of finished products, and others, to prevent the use of crude heparin that might contain oversulfated chondroitin sulfate (OSCS) or nonporcine material (especially ruminant material) contaminants. This guidance on crude heparin recommends strategies to test for contamination and should be used in addition to the US Pharmacopeia monograph testing required for other forms of heparin to detect the presence of OSCS. The guidance recommends that manufacturers test and confirm the species origin of crude heparin in each lot of every shipment before use in the manufacture or preparation of a drug or medical device containing heparin. The test method should be qualified for use in testing crude heparin and for the identification of species origin. The method should be based on good scientific principles. The guidance also recommends that manufacturers test for OSCS in crude heparin in each lot of every shipment before use, using a qualified test method that is suitable for detecting low levels of OSCS concentrations and is based on good scientific principles.

FDA Approves New Devices

V ITROS Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls from OrthoClinical Diagnostics Inc, Rochester, New York. This device is indicated for VITROS Immunodiagnostic Products HBeAg Reagent PackVfor the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2-21 years old) serum from individuals who have symptoms of hepatitis orwho may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B or recovery from hepatitis B infection. VITROS Immunodiagnostic Products HBeAG Calibrator is for use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems for the in vitro qualitative detection of HBeAg in human adult and pediatric (2-21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for HBV infection. VITROS Immunodiagnostic Products HBeAg Controls is for use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems when used for the in vitro qualitative detection of HBeAg in human adult and pediatric (2-21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for HBV infection when using the VITROS Immunodiagnostic Products HBeAg Reagent Pack. In addition, the Food and Drug Administration (FDA) approved EXOSEAL VascularClosureDevice fromCordisCorporation, Bridgewater, New Jersey, for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures using a standard 5F, 6F, or 7F vascular sheath introducer with up to 12-cm working length. In addition, the EXOSEAL VCD is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6F vascular sheath introducer up to 12-cm working length, and who have received preprocedural and/or intraprocedural glycoprotein IIb/IIIa inhibitor therapy. TheFDAalso approved Solesta from Oceana Therapeutics Inc, Edison, New Jersey, for the treatment of patients with fecal incontinencewho are 18 years and older and who have failed conservative therapy (eg, diet, fiber therapy, antimotility medications). In addition, FDA approved Abbott RealTimeHCV,AbbottRealTimeHCVAmplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional uracil-Nglycosylase for use in conjunction with Abbott RealTime HCV from Abbott Molecular Inc, Des Plaines, Illinois. This device is indicated for Abbott RealTime HCV Amplification Reagent Kit; Abbott RealTimeHCVassay is an in vitro reverse transcriptionpolymerase chain reaction assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000ry4 instruments for the quantitation of hepatitis C virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 have been validated for quantitation in the assay. The Abbott RealTime HCV assay is intended for use as an aid in the management of HCVinfected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be used to predict sustained and nonsustained virological response toHCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a or 2b plus ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established. The Abbott RealTime HCV assay is not for DOI 10.1097/JCE.0b013e31822f80f2

Food and Drug Administration Issues Draft Guidance on In Vitro Diagnostic Devices

O n January 5, 2011, the Food and Drug Administration (FDA) announced the availability of a draft guidance that recommends studies for establishing the performance characteristics of in vitro diagnostic devices (IVDs) for the detection of antibodies toBorrelia burgdorferi in human serum, plasma, and blood. Serological testing for antibodies to B burgdorferi in Lyme disease diagnostics is a 2-step procedure. Initial testing is done by an enzyme immunoassay or immunofluorescent assay; specimens yielding positive or equivocal results are tested further by using a Western immunoblot assay. Specimens negative by a sensitive enzyme immunoassay or immunofluorescent assay do not need further testing. Results from Western blot assays for antibodies toBburgdorferi are supplemental rather than confirmatory. Two-step positive results provide supportive evidence of exposure to B burgdorferi, which could support a clinical diagnosis of Lyme disease but should not be used as a sole criterion for diagnosis. A manufacturer who intends to market an IVD for detection of antibodies to B burgdorferi must conform to the general controls of the Federal Food, Drug, and Cosmetic Act and, unless exempt, obtain premarket clearance or approval prior to marketing the device. On the same day, the FDA announced the availability of a draft guidance that provides industry and agency staff with recommendations for studies to establish the analytical and clinical performance of nucleic acid–based IVDs intended for the detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and S aureus (SA). These devices are used to aid in the prevention and control of MRSA/SA infections in healthcare settings. This guidance provides detailed information on the types of studies that the FDA recommends using to support class II premarket submissions for these devices. The guidance includes examples of MRSA and SA strains recommended for analytical sensitivity and inclusivity studies and examples of microorganisms recommended for analytical specificity studies. This document is limited to studies intended to establish the performance characteristics of devices that detect the MRSA/SA genome (nucleic acid). It does not address the detection of MRSA/SA antigens or serological response from the host to the MRSA/SA antigens, nor does it address establishing performance of nonMRSA/SA components of multianalyte or multiplex devices.

FDA Approves DuraSeal Spine Sealant System

T he Food and Drug Administration (FDA) approved theDuraSeal Spine Sealant System from Covidien, in Waltham, Massachusetts, September 4, 2009. The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid from leaking out of the incision site. The system consists of components to prepare an absorbable sealant (polyethylene glycol hydrogel) and a delivery system (an applicator and spray tips, packaged in a single-use kit). The sealant is composed of 2 solutions (polyethylene glycol ester and trilysine amine) referred to as the blue and clear precursor solutions. When mixed, the 2 solutions rapidly combine (in situ polymerization) to form a sealant gel that seals the dura mater. The dura mater is the tough, outermost, fibrous membrane that covers the brain and spinal cord and lines the inner surface of the skull. The sealant is sprayed or layered onto the sutured incision site. It adheres to the tissue, and it is more than 90% water. The blue color helps the surgeonsee the sealant, which naturally breaks down and is absorbed within 4 to 8 weeks, enough time to allow for healing. The DuraSeal Dural Sealant System is used as an aid during spinal surgery to prevent cerebrospinal fluid leakage along dural sutures by forming a watertight closure. The DuraSeal Spine Sealant has demonstrated to seal 100%of sutured dural incisions as evaluated intraoperatively. DuraSeal should not be applied to confined bony structures where nerves are present since neural compression may result because of hydrogel swelling. The hydrogel may swell up to 50% of its size in any dimension.

FDA Approves Quick-Close Vascular Suturing System

T he Food and Drug Administration (FDA) April 8 approved the Quick-Close Vascular Suturing System, from Interventional Therapies, LLC, Westport, Connecticut. The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The Suture Applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester [Novafil]) fitted with stainless steel rings. The Cinch Applier has a syringe-type shape with an extended handle. The Suture Applier is used to gain access to the puncture site of the femoral artery. Using manual control, and relying on the sense of touch, the device is used to place one end of the suture through one edge of the arterial wound. The Suture Applier is then repositioned, and the other end of the suture is inserted through the opposite edge of the wound site. As the Suture Applier is withdrawn from the wound site, the 24-in length of the suture is forced out of its housing. The SutureApplier places a single stitch of a nonabsorbable, singlethread suture to the wound site. The Cinch Applier gathers the 2 ends of the suture, and then it places a stainless steel ring that acts in place of a knot to secure the suture in a closed position to stop the bleeding. The Quick-Close Vascular Suturing System is used to close a puncture in the femoral artery following surgery. It is designed for use in small vascular punctures in blood vessels with diameters of 4 mm or larger. The QuickClose Vascular Suturing System is an alternative to applying manual pressure (compression) to stop bleeding and allows patients to become mobile sooner than is possible with standard compression methods.