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Boston Scientific to Distribute Bard's Lutonix Drug-Coated Balloon for Blockages in Leg Arteries
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Lutonix Drug-Coated Balloon |
February 10, 2015 -- Boston Scientific (NYSE: BSX) and C. R. Bard, Inc. (NYSE: BCR) have announced that Bard's Lutonix® 035 drug-coated balloon will be distributed in the United States by Boston Scientific. The specific terms of the agreement were not disclosed.
The Lutonix was the first drug-coated balloon (DCB) approved by the FDA for use in the superficial femoral or popliteal arteries in the leg. That was four months ago.
Yesterday's announcement represents a significant leap forward for the device, in that Boston Scientific has a larger sales force and revenues more than twice that of C.R. Bard. Moreover, Boston Scientific has a broad base of device offerings used by interventional cardiologists, radiologists and vascular surgeons, which gives the company the advantage of packaging the Lutonix DCB with other interventional products, such as stents, balloons, atherectomy devices, pacemakers, ICDs, and imaging systems, none of which currently are offered by C.R. Bard.
This distribution agreement puts Boston Scientific directly in competition with Medtronic plc, a company with a similar product portfolio, whose IN.PACT Admiral DCB was approved last month and launched earlier this week.
Results from all of the DCB trials have shown a significant improvement in outcomes over the standard PTA non-coated balloons. Unlike drug-eluting stents, used in the coronary arteries, the balloons have the advantage of leaving nothing behind. Currently both bare-metal stents and one drug-eluting stent, Cook's Zilver PTX, are also used in the peripheral vessels. Like the drug-coated balloons, the Zilver PTX drug-eluting stent has shown significantly better outcomes than the standard non-coated balloons. Whether or not drug-coated balloons will trump the drug-eluting Zilver PTX stent is yet to be determined by future studies.
Both of these drug-coated balloons have been in use in Europe: the Lutonix 035 was approved there in 2012 while Medtronic's IN.PACT received European approval even earlier in 2009 and has been used in almost 100,000 patients to date.
A historical fact: C.R. Bard, the company that acquired Lutonix and is also the manufacturer of several models of PTA balloons, was the very first company to offer a coronary angioplasty balloon, back in the 1980s, the Gruentzig balloon catheter, which was a product of USCI, a division of C. R. Bard.
Yesterday's joint press release from Boston Scientific and C. R. Bard follows:
Boston Scientific And C. R. Bard Announce Distribution Agreement For Lutonix® Drug Coated Balloon
Agreement Extends Reach of Lutonix DCB and Provides Physicians with a Comprehensive Solution to Prepare and Treat Diseased Femoropopliteal Vessels
February 9, 2015 -- Marlborough, Massachusetts and Murray Hill, New Jersey -- Boston Scientific Corporation (NYSE: BSX) and C. R. Bard, Inc. (NYSE: BCR) ("Bard") today announced that Boston Scientific will distribute the Lutonix® 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) in the United States under a limited distribution agreement reached with Bard. Terms of the agreement were not disclosed.
The Lutonix DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel that is designed to decrease the incidence of restenosis and improve patency in patients with stenosed femoropopliteal vessels, often seen with peripheral artery disease. Lutonix DCB was the first FDA-approved DCB in the U.S.
"Drug-coated balloons are a growing part of the treatment algorithm for peripheral artery disease and provide an alternative in the event a physician chooses not to place a permanent implant or scaffold," said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. "We believe Bard's Lutonix DCB is a great addition to our broad portfolio of vascular products."
"This agreement is designed to expand the reach of the Lutonix DCB and will afford more patients suffering from peripheral artery disease an opportunity to benefit from this innovative technology and clinically-proven therapy," said Steve Williamson, president of Bard Peripheral Vascular, Inc., one of Bard's subsidiaries.
About Peripheral Artery Disease
Peripheral artery disease (PAD) is a circulatory system disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb. It is estimated that 12-14 percent of the general population is affected by PAD [1].
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
About C. R. Bard, Inc.
C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, N.J., is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.
[1] Shammas NW (2007). "Epidemiology, classification, and modifiable risk factors of peripheral arterial disease." Vasc Health Risk Manag 3 (2): 229–34. doi:10.2147/vhrm.2007.3.2.229. PMC 1994028. PMID 17580733
Cautionary Statement Regarding Forward-Looking Statements for Boston Scientific and C. R. Bard, Inc.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on each company's beliefs, assumptions and estimates using information available to such company at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding the distribution of Lutonix DCB, product performance and impact and competitive offerings. If the underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by these forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect the ability of such company ability to implement its business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond such company's control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in such company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q filed or file hereafter by such company. For C. R Bard, Inc. please also refer to the Cautionary Statement Regarding Forward-Looking Information in Bard's September 30, 2014 Form 10-Q for more detailed information about these and other factors that may cause actual results to differ materially from those expressed or implied. Each company disclaims any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in such company's expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Reported by Burt Cohen, February 10, 2015 |
