SOURCE: iData Research

iData Research

December 21, 2015 14:00 ET

Medtronic's Strategic Acquisition of Covidien Made Them the Leading Competitor in the Atherectomy Device Market

Positive Clinical Data, the Development of New Technology and the Recent FDA Approval of Two Drug Coated Balloons Are Increasing Atherectomy Procedural Volume and Driving Growth in the Demand for Atherectomy Devices

VANCOUVER, BC--(Marketwired - December 21, 2015) - According to a new series of reports on the U.S. markets for peripheral vascular devices and accessories by iData Research (, positive clinical data and the development of new technology are increasing atherectomy procedural volume and driving growth in the demand for atherectomy devices. Additionally, the prevalence of peripheral vascular procedures resulting in high restenosis rates and the lack of alternative treatments will help fuel the artherectomy device market.

The market is experiencing higher growth in below-the-knee procedures. Several clinical trials, including the Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities (DEFINITIVE LE) and Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis (OASIS) trials have produced encouraging results for atherectomy device usage.

"The average selling price (ASP) of atherectomy devices is expected to decline modestly over the forecast period as peripheral atherectomy procedures continue to shift towards more cost sensitive outpatient settings," explains Dr. Kamran Zamanian, CEO of iData. Historically, Covidien reduced their prices in 2007 after their acquisition of FoxHollow's SilverHawk® line of products in an attempt to gain market share. Because of Covidien's strong position in the atherectomy market, this led to a downward pressure on price. However, recent FDA approval of two drug coated balloons is expected to exert a positive influence on atherectomy device sales over the forecast period.

Twelve-month results from the DEFINITIVE AR study has demonstrated that the combination of directional atherectomy and anti-restenosis therapy (DAART) with drug-coated balloons improve patency in long lesions and lesions with severe calcification. Growth in the volume of DAART procedures will drive unit sales of atherectomy devices over the forecast period. In June 2015, the U.S. Centers for Medicare & Medicaid Services (CMS) improved the pass-through payment for drug-coated balloons (DCB). The improvement has the potential to drive usage of DCB in the outpatient setting and contribute to growth in the volume of procedures utilizing atherectomy devices.

In 2015, the leading competitor in the peripheral atherectomy device market was Medtronic. Medtronic acquired Covidien in 2015. Prior to the acquisition, Covidien was the leading competitor in the market. Covidien acquired ev3 in 2010. Previous to this acquisition, ev3 had been the market leader since 2007, when they acquired the FoxHollow's SilverHawk® family of products. Over the forecast period, Medtronic is expected to maintain its leadership position in the peripheral atherectomy space, but will face increasing competition from Cardiovascular Systems Inc., its main rival.

DCBs are emerging as a promising technology for treating PAD. Medtronic and C.R. Bard were the only companies with FDA-approved DCBs in 2015. Spectranetics' Stellarex™ Drug Coated Balloon has demonstrated positive results in the ILLUMENATE trial series and is expected to be the third DCB to receive FDA approval. Commercialization of the Stellarex™ Drug Coated Balloon in the U.S. could happen as early as 2017.

For Further Information

More on the atherectomy device market in the US can be found in a report series published by iData Research entitled the US Markets for Peripheral Vascular Devices and Accessories Report Suite. The suite covers reports on the following markets: Peripheral Vascular Stent Market, PTA Balloon Catheter Market, Atherectomy Device Market, Chronic Total Occlusion (CTO) Device Market, Embolic Protection Device Market, Stent Graft Market, Surgical Graft Market, Diagnostic and Interventional Catheter Market, Diagnostic and Interventional Guidewire Market, Introducer Sheath Market, Inferior Vena Cava Filter Market, Arteriovenous (AV) Access Thrombectomy Device Market, Vascular Closure Device Market, and Transcatheter Embolization Device Market.

Reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players' success strategies in each market and segment.

To find out more about peripheral vascular device market data or procedure data, register online or email us at for a US Markets for Peripheral Vascular Devices and Accessories Report Suite report series brochure and synopsis.

About iData Research

iData Research ( is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Vascular Access, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Cardiovascular, Ophthalmics, Endoscopy, Gynecology, Urology, Dental, and more.

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