Sealants, glues and securement products

See the 2012 report #S190, “Worldwide Market for Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2012-2017”.

Wounds have been closed and secured through the use of suture materials since ancient Egyptian times. In the modern medical age, suture materials have evolved through a succession of stages from non-resorbable, to resorbable, to stapling devices. Since sutures still represent the majority of products used for wound closure and securement, it is important to discuss this class of products and their relationship with adjunctive measures, and with newer products under development.

There are six main categories of closure and securement devices as discussed below:

  • Sutures, Staples, and Other Mechanical Closure Devices
  • Tapes
  • Hemostats
  • Fibrin and Other Sealants
  • High-Strength Medical Adhesives
  • Post-Surgical Adhesion Prevention

This market may be subdivided into the following product categories: sutures, staples and other mechanical closure devices; tapes; hemostats; fibrin and other sealants; high-strength medical adhesives; and post-surgical adhesion prevention. The total securement market is growing at an aggregate of almost 10% annually.

Definition of Surgical Closure and Securement Products

Abbott Vascular/Abbott LaboratoriesPerclose ProGlideSuture-mediated closure device for 5-21F femoral artery access sites.
ProStar XLSuture-mediated closure device for 8.5-10F sheaths (8.5-24 F OUS).
StarClose SEClosure device delivers nitinol clips for 5-6F access sites.
Perclose A-TSuture-mediated closure device for 5-8F femoral artery access sites. Sold in US only.
AccessClosure Inc. (acquired by Cardinal Health in May 2014 for $320M cash.)MynxGripMynx sealant with Grip Technology added to distal end to seal the arteriotomy while expanding to fill tissue tract.
Mynx AceExtravascular PEG sealant that actively adheres to the artery for secure mechanical closure. Dissolves within 30 days.
ArstasisAxera 2 Access DeviceThis device creates a long, shallow-angle arteriotomy (5-6F) through the femoral artery wall. Resulting arteriotomy has self-sealing capability that requires only minimal compression for rapid hemostasis and eliminates the need to leave behind foreign material to close the puncture site.
Cardiva MedicalVascade Vascular Closure SystemUtilizes existing procedural sheath to obtain temporary hemostasis using a collapsible disc while delivering a thrombogenic, resorbable collagen patch extravascular to the arteriotomy. For closure of 5-7F femoral arteriotomies.
Cardiva Catalyst II and III manual assisted closure devicesManual closure assist device with a deployable nitinol disc that provides temporary hemostasis at the puncture site while puncture recoils to size of an 18-gauge needle. Wire has hemostatic coating to accelerate clotting. Catalyst III adds protamine sulfate coating for patients receiving heparin.
Cordis/J&JExoseal Vascular Closure DeviceUses existing procedural sheath to deliver resorbable PGA plug to the outside of the artery wall at the site of the arteriotomy. For closure of 5-7F femoral arteriotomies.
FDA approved May 2011.
Innovasa Corp.Stat*SealButton-like device with attached medicated foam-tip bandage. Tip is inserted into the femoral puncture tract and remainder of device rests on skin around puncture site. Facilitates hemostasis via targeted focal pressure combined with the hydrophilic drying and pro-coagulant effect of the foam tip, which is medicated with chitosan. After hemostasis is achieved, the device is completely removed from the patient.
Available in over the wire (for deeper insertion in the puncture tract) and topical versionsFDA cleared.
InSeal Medical Ltd. (Israel; a fully owned subsidiary of E-Pacing Inc.)InSeal Intravascular Closure DeviceSelf-expanding nitinol frame covered with biodegradable membrane for closure of 14-21F punctures in vessels 6-10mm diameter. Device is delivered using procedure sheath (no sheath exchange required); membrane covers puncture and uses blood pressure to seal against vessel wall. Delivery and deployment take less than 2 minutes.
In clinical development for use following large-bore procedures such as TAVR (transcatheter aortic valve replacement) and EVAR (endovascular aortic aneurysm repair).
Morris Innovative Inc.CombiClose/ControlCloseDevices deliver a plug of ExtraCellular Matrix, made of porcine small intestine submucosa (SIS), to the inside of the vessel wall, which seals the arteriotomy and promotes remodeling of the host tissue within 30 days. For 5-8F punctures.
Vascular Closure Devices (formerly FISH)
St. Jude MedicalAngioSealIntra-arterial anchor, suture, and collagen components form ÒsandwichÓ to close arteriotomy. FDA labeled for immediate restick and for 20-min ambulation/60-min discharge for diagnostic cases. Components resorb within 90 days.
AngioSeal EvolutionNext-generation AngioSeal with automated collagen compaction and enhanced ease of use.
Transluminal Technologies LLCVelox CD Vascular Closure DeviceConsists of delivery device and metal closure implant made of a proprietary magnesium alloy. Intended for closure of femoral arteriotomies. Implant comprises an intraluminal footplate that absorbs in about 24 hours and an extraluminal plug that absorbs in two weeks.
CE marked July 2014.
Vascular Closure Systems Inc.FastSeal Bioabsorbable Vascular Access Closure SystemSystem deploys a non-collagen, double-disc polymer sealing element that is positioned with components resting on both the inner and outer side of the artery, sandwiching the puncture site and enabling hemostasis within 60 seconds.
FIH trial completed for 6-8F puncture closure system. OUS commercialization is expected to begin in 2014. A large-bore (18-F) system is also in early-stage development.

Source: MedMarket Diligence, LLC; Report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013.”

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