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October 1, 2015

Tryton Medical Announces Publication of Post Hoc Analysis of Randomized Clinical Trial in Treatment of Bifurcation Lesions using Tryton Side Branch Stent

Analysis showed reductions in target vessel failure and improved side branch percent diameter stenosis in patients with a coronary bifurcation lesion in vessels 2.25mm in diameter or greater

September 30, 2015 06:30 AM Eastern Daylight Time

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, today announced that results of a post hoc analysis of the pivotal Tryton Randomized Clinical Trial (RCT) have been published in the peer-reviewed journal Catheterization and Cardiovascular Interventions (CCI), the official publication of the Society for Cardiovascular Angiography and Interventions (SCAI). The analysis, “Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study,” examines the use of the Tryton Side Branch Stent compared with provisional stenting in the intended treatment population of patients with a coronary bifurcation lesion in vessels 2.25mm in diameter or greater determined by quantitative coronary angiography (QCA).

“We welcome the results of this post hoc analysis in patients with large side branches as an important step towards bringing a dedicated stent to cardiologists in the United States, and addressing challenges in treating significant coronary bifurcation lesions”

The study authors, led by Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, conclude that treatment with the Tryton Side Branch Stent showed reductions in target vessel failure and improved side branch percent diameter stenosis in the population of patients with lesions involving side branches that were 2.25mm in diameter or greater. Both the Tryton Side Branch Stent and provisional treatment strategies were shown to have similarly low rates of stent thrombosis and no cardiac deaths were reported at nine months.

“Coronary bifurcation lesions present a number of challenges for interventional cardiologists because each patient can present with varying vessel sizes and there is a wide range of angulations between the main vessel and side branch,” said Dr. Leon. “For the treatment of bifurcation lesions involving significant side branches, this analysis of the pivotal Tryton RCT provides strong support for the safety and efficacy of the Tryton Side Branch Stent compared with a provisional stenting strategy.”

In the post hoc analysis of 289 patients with a coronary bifurcation lesion involving a side branch greater than or equal to 2.25mm in diameter, target vessel failure, the primary endpoint, was numerically lower among the Tryton group compared to the provisional group. The Tryton Side Branch Stent demonstrated a statistically significant lower side branch percent diameter stenosis at nine month follow up compared with the provisional group (30.4% vs. 40.6%, P = 0.004). In addition, the Tryton Side Branch Stent reduced the need for additional side branch “bail-out” stenting compared with the provisional approach (0.7% vs. 5.6%, P = 0.02). There was no significant difference in the rate of binary restenosis.

“We welcome the results of this post hoc analysis in patients with large side branches as an important step towards bringing a dedicated stent to cardiologists in the United States, and addressing challenges in treating significant coronary bifurcation lesions,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “We recently completed enrollment in the Tryton Confirmatory Study, a single-arm study of our dedicated stent designed to confirm results from the pivotal Tryton RCT study in our intended population of patients with coronary bifurcation lesions involving side branches that are 2.25mm in diameter or greater. We plan to present findings from this study at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting in the coming weeks.”

About Tryton Side Branch Stent

Tryton Side Branch Stent System is built using proprietary Tri-ZONE® technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel. Tryton Side Branch Stent has now been used to treat more than 11,000 patients worldwide. The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East & Africa, is investigational in the US, and is not available in Japan.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is the leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D., professor of medicine at Dartmouth Medical School/Dartmouth-Hitchcock Medical Center, to develop stents for the definitive treatment of bifurcation lesions. For more information please visit www.trytonmedical.com and follow the company on Twitter at @TrytonMedical1.

 

Source: Business Wire

News Releases Eluvia™ Drug-eluting Vascular Stent System Demonstrates 12-month Primary Patency Of 96.1 Percent

MAJESTIC Trial Data Support Strong Safety Profile with Low Target Lesion Revascularization Rate

Sep 28, 2015

MARLBOROUGH, Mass., Sept. 28, 2015 /PRNewswire/ — New 12-month clinical trial outcomes assessing the safety and performance of the Boston Scientific (NYSE: BSX) Eluvia™ Drug-Eluting Vascular Stent System reflect a primary patency rate1 of more than 96 percent. These results represent the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials. The Eluvia Stent System is an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), a result of peripheral artery disease (PAD).

Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7223457-boston-scientific-eluvia-clinical-trial/

Results from the MAJESTIC trial, which were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting in Lisbon, Portugal, also included a low 12-month target lesion revascularization (TLR) rate of 3.8 percent, with no observed stent fractures and no amputations.

“Achieving a 96 percent primary patency rate at one year, with low major adverse events, is exceptional,” said Professor Stefan Muller-Hulsbeck, M.D., PhD, principal investigator and chairman, Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology /Neuroradiology, Academic Hospitals Flensburg, Germany. “In my opinion, the sustained release of paclitaxel enabled by this technology could represent a significant advancement in the treatment of patients with peripheral arterial disease.”

The MAJESTIC trial, a prospective, multicenter clinical trial, enrolled 57 patients across Europe,Australia and New Zealand, with an average lesion length of 70.8 mm. The trial included a high percentage of complex lesions, with 46% of lesions classified as total occlusions and 65% identified as severely calcified.

Data from the MAJESTIC trial are expected to support global regulatory submissions. In addition, Boston Scientific has received an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA) to begin a global, pivotal study of the Eluvia Stent System. The study, named the IMPERIAL trial, is designed to support future regulatory submissions and patient enrollment is expected to begin in the coming months.

“The MAJESTIC trial demonstrates our commitment to bringing forward innovative therapies that can make a difference in the lives of patients with PAD who face risks of serious complications including infections and amputations,” said Jeff Mirviss, senior vice president and president, Peripheral Interventions, Boston Scientific. “The Eluvia Stent is built on a foundation of more than 15 years of design, development and clinical leadership in drug-eluting technologies at Boston Scientific.”

About the Eluvia Stent System
The Eluvia Stent System is the first stent specifically designed for deployment in the superficial femoral artery (SFA) that utilizes the anti-restenotic drug paclitaxel in conjunction with a polymer. This drug and polymer combination is intended to facilitate sustained release of the drug over the period of time when restenosis is most likely to occur, preventing tissue growth that might otherwise block the stented artery. The Eluvia Stent System is built on the Innova™ Stent System platform, consisting of a self-expanding nitinol stent and an advanced, 6F low-profile triaxial delivery systemfor added support and placement accuracy. The innovative stent architecture features a closed-cell design at each end of the stent for more predictable deployment, and an open-cell design along the stent body for improved flexibility, strength and fracture resistance. View or download an image of the Eluvia Stent System.

The Eluvia Stent System is pending CE Mark approval. In the U.S., the Eluvia Stent System is an investigational device and is not available for sale.

About Peripheral Artery Disease
Peripheral artery disease is a circulatory disorder that results from a build-up of plaque in one ormore 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 200 million people are affected by PAD worldwide.

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, visitwww.bostonscientific.com and connect on Twitter and Facebook.

Primary patency defined as duplex ultrasound peak systolic velocity ratio < 2.5 and absence of TLR or bypass; data reflect actual values (not Kaplan Meier estimates).

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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 our beliefs, assumptions and estimates using information available to us 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 clinical trials and impact of data and product performance. If our 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 our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our 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 our 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 our 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 we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our 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.

Source: Boston Scientific