SurModics Serene™ low friction, low particulate coatings

Leave your particulate concerns behind

Excellent Lubricity. Low Particulates. Now You Can Have Both.

SurModics Serene™ coatings are a breakthrough technology platform that delivers lubricity and durability while significantly reducing particulates.

The properties that make hydrophilic coatings more lubricious—absorbing and exuding water—also can make them more susceptible to generating particulates.1 Until now, medical device manufacturers have been faced with a challenge: how do we maintain coating lubricity and lower particulates at the same time?

Using its extensive expertise in coating technologies, SurModics has developed the solution to this dilemma. Serene coatings optimize lubricity and durability and set a new standard for low particulates.

Lower—The Logical Choice

Hydrophilic, lubricious coatings help successfully guide medical devices through complex human vasculature. Regulatory agencies, however, are increasingly interested in particulates generated from coated devices.

Particulate matter can come from the device manufacturing process, coating, product packaging and the procedure itself. Angioplasty or other coronary interventions, for example, can generate debris that may cause vascular obstructions.2-4 While medical device manufacturers cannot control all the variables that may generate particulates, they can specify a low-particulate device coating. As part of the coating integrity data for device submissions, the Food and Drug Administration (FDA) recommends that device manufacturers measure the total number and size of particulates generated in simulated use testing.5

The logical choice: lower particulate coatings that deliver the durability and lubricity both you and your customers want.

Proven Performance – In Vivo Results

Another recent study explored potential in vivo physiological effects of hydrogel wear particulates originating from the use of catheter-based vascular medical devices coated with lower- and higher- particulate hydrophilic lubricious coatings. Histologic examination of myocardial tissue revealed no histology sections containing coating particulates from devices using the Serene coating platform. Non-target organs (lung, liver, kidney and spleen) and downstream muscle also showed no evidence of particulates.7

Coat with Confidence

Serene coating technology has been used on FDA-cleared coronary and peripheral devices. This next-generation formulation has demonstrated excellent lubricity on a wide range of medical devices and substrates.8

Proven Performance – Bench Testing

In a direct comparison using a coronary simulated-use model, the SurModics Serene coating platform was shown to have fewer particulates than other coatings available on market-leading devices.6 Coating lubricity (friction force) was measured by placing coated devices between two pinch-pads compressed at a constant force. The higher the friction, the lower the lubricity. The figure on the right illustrates how the Serene coating platform also showed lower friction than competitive products. Particles > 10 micron (normalized to 1000) Coefficient of Friction Force

1000 800 600 400 200 0 0.02 0.04 0.06 0.08 0.10

PARTICULATES FRICTION

Serene Coating on PTCA Catheterslow particulate and low friction

more than 2.5X more frictionCommercial PTCA Catheter A

more than 3X more frictionCommercial PTCA Catheter B

Commercial PTCA Catheter C

AVERAGE COEFFICIENT OF FRICTION ON A VARIETY OF SUBSTRATES

Coef

ficie

nt o

f Fric

tion

0.2

0.4

0.6

0

1.0

0.8

1.2

1.4

Substrate Material

uncoated PEBAX®

uncoated TEFLON®

NYLON PEEK HDPE35D PEBAX®

72D PEBAX®

BRAIDED 40D PEBAX®

BRAIDED 63D PEBAX®

LOWER IS BETTER SurModics Serene™ Coatings

2X more friction

Our Expertise Fits Your Needs

In the absence of defined regulatory limits for acceptable levels of particulates, some device manufacturers have established their own thresholds. SurModics has the analytical tools, capabilities and experience needed to develop and implement the appropriate tests for a variety of device specifications. Whether coating catheters, guidewires, or stent delivery systems, we will work with you to apply the coating technologies that meet both your parameters and industry guidelines.

Coating Application

SurModics Serene coatings can be applied at customers’ manufacturing facilities or via SurModics contract manufacturing. Serene coatings use ambient temperature, rapid UV curing processes similar to those for other SurModics coatings. The result? Coatings that can be applied quickly, cost-effectively, consistently and to your specifications.

Through partnership with OakRiver Technology, SurModics offers turnkey manufacturing solutions. Coating equipment is available in a standard platform or it can be customized to meet unique device, manufacturing or facility requirements.

Working with SurModics

For more than 30 years, SurModics has helped companies advance products from concept to successful commercialization. For customers that want to take the coating process in-house, SurModics provides comprehensive training, technical and implementation support to ensure a smooth and efficient transfer of technology. We identify optimal technology solutions that reduce time-to-market and partner with our customers throughout the process.

SurModics is known for excellent product quality, service and support. After all, our business is built on helping customers succeed. For more information on how SurModics Serene coating technology can enhance your product or to initiate an evaluation, please contact us at 952-500-7000 or visit www.surmodics.com/serene-coatings.

References

1. Anderson, A.; Dallmier, A.; Chudzik, S.; Duran, L.; Guire, P.; Hergenrother, R.; et al. Technologies for the surface modification of biomaterials. In: Yaszemski, M.; Trantolo, D.; Lewandrowski, K.; Hasirci, V.; Altobelli, D.; Wise, D.; editors. Biomaterials in orthopedics. New York: Marcel Dekker; 2004, p. 93-148.

2. Webb, J.; Carere, R.; Virmani, R.; Baim, D.; Teirstein, P.; Whitlow, P.; McQueen, C.; Kolodgie, F.; Buller, E.; Dodek, A.; Mancini, G.; Oesterle, S. Retrieval and analysis of particulate debris after saphenous vein graft intervention. J. Am. Coll. Cardiol. 1999, 34, 468-475.

3. Bekkars, C.; Yazdani, S.; Virmani, R.; Waltenberger, J. Microvascular obstruction: Underlying pathophysiology and clinical diagnosis. J. Am. Coll. Cardiol. 2010, 55, 1649-1660.

4. Limbruno, U.; De Carlo, M.; Pistolesi, S.; Micheli, A.; Petronio A. S.; Camacci, T.; Fontanini, G.; Balbarini, A.; Mariani, M.; De Caterina, R. Distal embolization during primary angioplasty: Histopathologic features and predictability. Am. Heart J. 2005, 150, 102-108.

5. Guidance for industry and FDA staff: non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. Food and Drug Administration, guidance document no. 1545, 2010.

6. SurModics data on file.7. Babcock, D.; Hergenrother, R.; Craig, D.; Kolodgie, F.; Virmani, R.; In vivo distribution of particulate matter from coated angioplasty

balloon catheters. Biomaterials. 2013, 34(13): 3196-3205.8. SurModics data on file.

Serene is a trademark of SurModics, Inc.Pebax is a registered trademark of ARKEMA or its affiliates.Teflon is a registered trademark of E. I. du Pont de Nemours and Company or its affiliates.

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SurModics, Inc. 9924 West 74th StreetEden Prairie, MN 55344 USAToll-free: 1-866-787-6639Phone: 952-500-7000Fax: 952-500-7001www.surmodics.com© 2014 SurModics, Inc. All rights reserved. MDSC0213.02