Global Closure devices Market - 2021-2028
The Closure devices market. Size was valued at US$ XX billion in 2020 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Closure devices have emerged as an effective alternative to traditional mechanical compression for femoral artery closure and are widely used in patients undergoing catheterization via the femoral route. They are inserted at the end of a procedure. The devices available fall into two categories, passive closure devices and active closure devices. Passive vascular closure devices stop the bleeding with the use of material that leads to the formation of blood clots or by way of mechanical compression.
The growing risk of heart stroke, along with the increasing population suffering from various vascular diseases, will rise the market growth. Technological innovations and developments will drive the closure devices market in the forecast period.
According to the Centers for Disease Control and Prevention (CDC), approximately every 40 seconds, an American will have a heart attack. Every year, 805,000 Americans have a heart attack, 605,000 of them for the first time. According to WHO, cardiovascular diseases (CVDs) are the number 1 cause of death globally, taking an estimated 17.9 million lives each year. According to the latest worldwide statistics calculated globally, nearly 18.6 million people died of cardiovascular disease in 2019,.Which reflects a 17.1% increase over the past decade.
Approximately 7 million invasive cardiovascular procedures are performed worldwide each year. Because the number of cardiovascular procedures performed via the femoral artery approach continues to increase, effective arterial hemostasis techniques are essential to high-quality patient care. Arteriotomy closure devices (ACDs) are used to decrease vascular complications, reduce the time to hemostasis and ambulation. Subsequently, several generations of passive and active ACDs have been introduced that incorporate suture, collagen plug, nitinol clip, and other mechanisms to achieve hemostasis.
Closure devices are used to close a defect or an opening between the right and left sides of the heart. Some of these congenital disabilities are located in the wall (septum) between the upper chambers (atria) of the heart: Patent Foramen Ovale (PFO) and Atrial Septal Defect (ASD).
The Angio-Seal closure device achieves hemostasis by anchoring a collagen plug to the anterior vessel wall through a sheath delivery system.In recent times a new generation of the Angio-Seal device (Angio-Seal STS Platform™) became available. Angio-Seal STS simplifies the deployment process for the operator; by eliminating the post-placement spring, the procedure is concluded in the cath lab.
Closure devices were introduced to reduce access site bleeding complications and reduce the time to hemostasis and ambulation. There are two types of closure devices. Passive devices include clamps for assisted compression and newer technologies, like assisted coagulant patches and sealants. Active devices use sutures, collagen plugs, nitinol clips and other mechanisms to achieve hemostasis.
The FDA granted market approval to Rex Medical's bioresorbable Closer Vascular Sealing System (VSS) to achieve rapid hemostasis of femoral artery catheterizations. The system consists of an insertion sheath, dilator and an implant contained in a delivery system. They use a patch placed against the artery wall and is secured outside the vessel by an attached suture is connected to two bioresorbable spheres. The suture helps to bring the patch and spheres together. The patch, spheres are made of polylactide-co-glycolide acid copolymer and suture is made of polydioxanone. The device components dissolve inside the body after the vessel heals.
The vast majority of large-bore vessel closure is performed by percutaneous suture-based techniques like the Prostar® XL and multiple ProGlide® (Abbott Vascular) vascular closure devices (VCD). Both devices are predominantly inserted using a pre-closure technique.
The MANTA™ VCD (Essential Medical) is a collagen-based closure device. It consists of a poly-lactic co glycolic toggle within the artery, connected to a bovine collagen plug, exterior to the vessel wall.
The use of large-bore closure devices is expected to rise given the growth in TAVI and structural heart procedures, percutaneous left ventricular assist device implantation, and endovascular interventions. Beyond the suture-based VCDs, other designs have now arrived-for instance, following results from the SAFE-MANTA trial, the Manta (Essential Medical), which combines a bioresorbable collagen plug and suture system to seal the puncture site, received FDA approval in February 2019. Manta, as well as the InClosure VCD (InSeal Medical) and PerQseal (Vivasure Medical), all have had CE Mark approval for years in Europe. The use of large-bore arteriotomies is peaking with the expanding market of structural heart interventions and MCS. Indeed, catheter-based techniques, such as EVAR and TAVI, have greatly replaced conventional surgical operations.
The use of percutaneous vascular closure devices has emerged as an alternative to manual compression in achieving hemostasis safely and timely while reducing time to ambulate and improve patients' comfort. The complications of using percutaneous vascular closure devices include hematoma, local bleeding, arteriovenous fistula formation, pseudoaneurysm and arterial leg ischemia. Management of these complications includes conservative treatment, blood transfusion and occasionally surgical repair.
Suture-based vascular closure devices (VCDs) can, in real-world practice, lead to complications and even death, analysis of a US Food and Drug Administration database confirms. These adverse outcomes varied by whether the VCD in question was the decades-old Prostar XL or the newer Perclose ProGlide (Abbott), which arrived on the US market in 2018. Particularly in high-risk patients, it's essential to choose a device that's easier to use and thus, in theory, would be less prone to complications, according to Case and colleagues.
Most VCDs are approved for arteriotomies between 5 and 8 F, with one device approved for up to 21 F. Major complications include infection and limb ischemia.
Active vascular closure devices use a variety of methods to directly close the entry site in the artery. For example, these devices include collagen-based and suture-based products or clips. These effectively close the access site but often require a part of the device to remain in the artery, which can cause complications. New devices use materials, such as polyethylene glycol, that dissolve after a short period of time. These are applied to the outside of the artery only and so are considered a more gentle option.
Active VCDs are categorized as suture devices, collagen plug devices or clips. The collagen plug Mynx device was investigated prospectively in 190 patients (50% interventional, 94% 6 Fr) and retrospectively in 238 patients (100% diagnostic and 6 Fr). Device success was achieved in 91-93%. Clip device the Starclose device (Abbott Vascular, Redwood City, Calif.) achieves hemostasis with a 4 mm nitinol clip implant.
Perclose (Abbott Vascular) offers suture-mediated VCDs that have evolved from the Prostar to the Techstar to the Closer, to the Perclose A-T, to the ProGlide. The success of the Perclose devices is 91-94%.The experience of 46 patients of both Techstar and MC, 76% of them stated they would prefer Techstar, and 17% would prefer MC (p < 0.001).47. A cost analysis suggested that Techstar compared with MC reduced post-PCI costs by 13% by facilitating earlier discharge.
Femoral vascular closure devices are acting as powerful tools for interventional cardiologists and proceduralists to achieve hemostasis at the catheterization entry site. One of the main arteries of the lower limb is the femoral artery and it is one of the most common access site to perform a cardiac catheterization. The common femoral artery is an extension of the external iliac artery (a terminal branch of the abdominal aorta). The indication of using a femoral vascular closure device is to achieve hemostasis through successful closure of the femoral artery puncture site and to decrease the time to attaining successful hemostasis. Hemostasis for large bore access sites for structural interventions is routinely achieved using femoral vascular closure devices.
High adoption of advanced devices providing enhanced cardiac care.Growing admissions with heart stroke and safety and effectiveness of vascular closure devices in prevention of access site complications in acute stroke patient receiving intravenous (IV) or intra-arterial (IA) IV tissue plasminogen activator. Patience preference for well-equipped emergency cardiac will increase the segment growth.
According to the CDC Percent of visits to emergency departments with coronary artery disease, ischemic heart disease, or history of myocardial infarction indicated on the medical record: 7.2%. During the first lockdown, which began in March 2020, daily hospitalizations for heart failure and AMI declined by 54%. The rates began to increase during April and almost returned to baseline by June. A total of 17 417 emergency hospital admissions (10 215 for heart failure, 7202 for cardiac arrhythmias) and 1832 interventions (749 ablations, 1083 implants) were included.
Availability of technologically advanced medical facilities, rising incidences of cardiovascular diseases and use of closure devices will rise the market in this region. Technological advances and increased hospital admissions for cardiac problems. The presence of most of the key players in this region is one more factor that will drive its market growth. According to the Centers for Disease Control and Prevention, more than 454,000 hospitalizations related to atrial fibrillation for primary diagnosis are reported each year in the U.S.
Essential Medical Inc. is a privately held medical device company aiming to develop and commercialize new vascular closure devices for femoral punctures after diagnostic and interventional cardiac catheterization procedures. It received U.S. Food and Drug Administration (FDA) clearance for its large bore Manta Vascular Closure Device.
Closure Devices market key players are Intuitive Surgical, Inc, Johnson & Johnson Services Inc, Pfizer Inc, Lupin, Siemens, Koninklijke Philips NV, Intuitive Surgical, Inc, Cook, Medtronic, Teva Pharmaceutical Industries Ltd, Medsinglong Co Ltd., Guangzhou Medunion Technologies Co.ltd and Guangzhou Maya Medical Equipment.Co.ltd.
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