silverhawk covidien

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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 markets for peripheral vascular devices in the US can be found in the latest report suite published by iData entitled US Peripheral Vascular Device Market Report Suite – 2016, which covers the US as well as the following markets: peripheral vascular stents, PTA balloon catheters, atherectomy devices, chronic total occlusion devices, embolic protection devices, stent-grafts, surgical grafts, AV access thrombectomy devices, inferior vena cava filters, diagnostic and interventional catheters, standard and hydrophilic guidewires, introducer sheaths, vascular closure devices, and transcatheter embolization devices.

The iData series on the market for peripheral vascular devices also covers China, India, Japan, and 15 countries in Europe. Full reports 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. Register online or email us at [email protected] for a US Peripheral Vascular Device Market – 2016 report brochure and synopsis.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.


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