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U.S. Peripheral CTO Device Market share|analysis|trends|overview|forecast to 2026

(Medical-NewsWire.com, October 30, 2019 ) Market Overview

• Chronic total occlusions (CTOs) is a challenging lesion subset in the peripheral circulation. CTOs, particularly long or heavily calcified have been the domain of surgeons for distal bypass. Although, surgery is still an option in some patients, the explosion of crossing technologies and atherectomy devices has allowed several endovascular specialists to tackle these lesions with a greater success rates.



Market Dynamics

• The major driving forces are the increasing number of regulatory approvals, and the increasing number of pipeline products.

• The increasing number of regulatory approvals is expected to boost the market. For instance, in January 2019, XableCath, Inc., have received the U.S. Food and Drug Administration (FDA) approval for Peripheral Crossing Catheters, XableCath blunt and abrasion tip catheters. Also, in April 2018, Asahi Intecc Co., Ltd. have received US Food and Drug Administration approval for a chronic total occlusion (CTO) Corsair and Corsair Pro microcatheters and its coronary guidewires that include the MiracleBros series, Confianza series, Fielder series, and Gaia series, in the United States. Thus, the increasing number of regulatory approvals is driving the market.

• The increasing number of pipeline products are expected to boost the market. For instance, in April 2018, Asahi Intecc Co., Ltd. have received US Food and Drug Administration approval for chronic total occlusion (CTO) indication for its Corsair and Corsair Pro microcatheters and its coronary guidewires that include the MiracleBros series, Confianza series, Fielder series, and Gaia series. It is the first expanded indication for Asahi devices in the United States. Also, in March 2018, Reflow Medical have started clinical study of its Reflow Wingman catheters exploring the device’s ability to cross chronic total occlusions in peripheral lesions. The ability to cross CTOs is directly related to acute procedural success and favorable long-term outcomes, including preventing the need for either bypass surgery or amputation. Thus, the increasing number of pipeline products are driving the market.

• However, increasing number of substitute products is restraining the growth of the market. For instance, in August 2018, Eximo Medical Ltd. have received 510(k) clearance from the U. S. Food & Drug Administration (FDA) for its B-Laser Atherectomy System for Peripheral Artery Disease (PAD). B-Laser is a transformative 355nm wavelength laser technology designed to address unmet clinical needs for treating multiple vascular indications. Also, in June 2018, Medtronic plc have received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of the IN.PACT Admiral Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).

Market Segmentation

• The U.S. peripheral CTO device market can be segmented by device type into crossing CTO device, TruePath, Viance Device, Re-entry device, CenterCross CTO device, Prodigy and CrossLock and others.

• The crossing CTO device segment is expected to grow at a high rate over the forecast period. Crossing CTO device is a unique system designed to achieve intraluminal penetration over long occlusions. It is approved for coronary and peripheral applications. The generator is controlled with a foot switch with a high frequency transducer and the Crosser catheter. The increasing number of clinical studies on crossing CTO device is one of the key factor fueling the U.S peripheral CTO device market growth. For instance, in March 2018, Reflow Medical have started clinical study of its Reflow Wingman catheters exploring the device’s ability to cross chronic total occlusions in peripheral lesions. Also, in November 2017, SoundBite Medical Solutions, Inc., have started a clinical study on SoundBite Crossing System – Peripheral. Thus, the increasing number of clinical trials on crossing CTO devices is driving the market.

• The Re-entry device segment is expected to grow at a high rate over the forecast period. This is owing to presence of key players manufacturing the Re-entry devices. For instance, Cordis Corporation have introduced the Outback Elite re-entry catheter in the United States. The new product in the Cordis portfolio to treatment patients with chronic total occlusions (CTOs) in peripheral artery disease add to a suite of specialty and workhorse solutions designed to support physicians in crossing the most complex lesions. Thus, the presence of key players manufacturing the re-entry devices are driving the market.

• The U.S. peripheral CTO device market can be segmented by end-user into hospitals, ambulatory surgical centers, and others.

• Hospitals account for a major share of the U.S. peripheral CTO devices market owing to better accessibility to CTO devices procedure during chronic total occlusion. Hospitals procure medical products, accessories, and consumables in a bulk quantity and engage closely with suppliers and manufacturers, reimbursement authorities, and government agencies.





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Competitive Analysis

• The major players operating in the U.S. peripheral CTO devices market are Medtronic, Boston Scientific Corporation, Avinger, Inc., Cardinal Health, Koninklijke Philips N.V., Cook Medical Incorporated, C.R. Bard, Baylis Medical Company, BTG Vascular, and Soundbite Medical Solutions.

• The key players are adopting various strategies such as product launches, mergers & acquisitions, partnerships, and collaborations, which are contributing to the growth of the U.S. peripheral CTO devices market. For instance,

• In December 18, 2018, Soundbite Medical Solutions has received CE mark for SoundBite™ Crossing System Peripheral Gen 2, an improved version of its shockwave-based technology platform that is intended for the treatment of peripheral Chronic Total Occlusions (CTOs).

• On June 12, 2018, SoundBite Medical Solutions Inc. (SBMS) received $5.2 million second and final tranche of Series A financing, bringing the total proceeds raised in the Series A financing to $25 million.

• In June 2017, Philips relaunched Pioneer Plus catheter, the only re-entry device with intravascular ultrasound guidance.





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Source: EmailWire.Com

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