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BIOTRONIKQuality in every detail
“Quality isn‘t something that can beargued into an article or promised intoit. It must be put there. If it isn‘t putthere, the finest sales talk in the worldwon‘t act as a substitute.”C.G. CampbellUS Scientist
Quality in every detailA history of firsts:From creating one of the world‘ssmallest ICDs, to launching thefirst remote monitoring system,to the revolutionary BIOTRONIKHome Monitoring of today, we area company that continually strivesto break new ground.“We are what we repeatedly do.Excellence, then, is not an act, but a habit.”Aristotle, Greek philosopher
Dedicated to life. Passionate about quality.BIOTRONIK is in the business of maintaining lives,enhancing lives, saving lives. And since the day westarted back in 1963, quality has walked hand in handwith those aspirations. Now, more than two milliondevices later, we continue to reinforce this commitmentthrough research, collaboration, and master craftsmanship. This is why patients and physicians alike trust ourexpertise. Because at BIOTRONIK, quality, reliability, andprogress are not just words; they are words to live by.
Our finger is on the pulseListening is the way forward.Our priorities are clearly defined. The well-being of patients is alwaysin the forefront. We are equally as committed to meeting the needs andexpectations of the physicians and healthcare professionals we workso closely with. This is why we continuously strive for better communication and the sharing of ideas through global forums, annual panels,scientific surveys, workshops, and extensive educational programs.With so many bright minds at our disposal, it is obvious to see why weare in the position to create innovation after innovation.expert panelFor our expert panel, we annuallyinvolve numerous technical and clinical experts from around the world toexchange ideas and experiences thatfacilitate continuous enhancement oftherapy concepts.
“Experience is thebest teacher.”Proverb
“Progress lies not in enhancing what is,but in advancing toward what will be.”Khalil GibranLebanese–American writer
Progress backed by qualityInnovative solutions straight from the heart.BIOTRONIK is the pioneer in wireless monitoring technology. In fact, we were thefirst company to develop and introduce an internet-based remote monitoring systeminto the market. Since then, we have continued to push the boundaries with innovative,cutting-edge technologies in Home Monitoring. It is this pioneering spirit coupled withextensive customer research that continues to set us apart. Today, BIOTRONIK HomeMonitoring is available in over 55 different countries, optimizing patient managementin more than 3,800 clinics around the world.2000 Introduction of BIOTRONIK Home Monitoring 2003 First internet-based Home Monitoring system2006 First bidirectional telemetry and IEGM-Online HD 2009 First intelligent traffic light systemFirst and only FDA and CE approved remote monitoring systemto safely replace in-office follow-ups and to provide early detectionNominated for the prestigious German Federal President’s InnovationAward (“Deutscher Zukunftspreis”)
Expect more than a productQuality is not an end result, it is a process.At BIOTRONIK, we constantly seek out top-notch talentsand provide them with regular access to the most recent andrelevant educational programs. They add to our ever-expandingteam of experts providing research, development, distribution,and customer service all over the world. It is precisely thisextensive talent pool that enables us to continually developnew and fascinating technologies.2 mm2 Themagazinecoverfractal coating of our lead tip is 100 timesthinner than a single human hair but has thecapacity to increase the electrically activesurface by a factor of over 1,000.Simply put, a 2 mm2 geometric surface canprovide an electrically active area the size of amagazine cover.
“By the work one knowsthe workman.”Jean de La FontaineFrench poet
“Everything should be madeas simple as possible. but not simpler.”Albert EinsteinGerman-born US physicist
Tried and tested –a thousand times overEvery second step – a quality step.Each and every BIOTRONIK employee is well aware that every otherstep during the production process is nothing less than a qualitycheck. This is why every single component, every process, and everyspecification is tested and monitored over and over again. For onelead alone, there are over 80 manufacturing steps backed up byover 300 quality checks. At BIOTRONIK, we do not just comply withindustry quality standards, we create new ones:Mechanical shock tests ensure that devices can withstand mechanical shocks during the implant procedureAccelerationStandard test1BIOTRONIK test1 x 500 g in 6 directions5 x 500 g in 6 directions 5 x 1,000 g in 6 directionsBarometric pressure tests ensure that implants are resistant to changes in atmospheric pressureduring storage and transportationLow pressure2High pressure2Standard test1Additional BIOTRONIK test1 hour @ 700 mbar 3,000 m height24 hours @ 250 mbar 10,000 m heightstaticcyclic1 hour @ 1,500 mbar 5 m water depthup to 4,500 mbar 35 m water depth1 DIN EN 45502-2-1, 45502-2-2/ISO 14708; 1g gravitational acceleration2 In comparison: standard atmospheric pressure 1013 mbar
Expertise equals successVascular intervention based on integrity, quality, and trust.It takes dedication, know-how, and superior engineering to create a sophisticated,high-quality device. But that is only half the equation. Improving patient care is theother half. This is the reason why we make sure that our cutting-edge products stayahead of the trends with a perfect balance of flexibility and strength. We even goabove and beyond industry standards to ensure you are getting the highest qualityproducts on the market.Tensile strength tests for peripheral balloon cathetersThe standard test for .018” peripheral balloon cathetersrequires a tensile strength of 10 Newton.1300%BIOTRONIK‘s Passeo-18 device exceeds the safetyety targetby up to 300%.Rated fatigue tests for balloon cathetersRepeated inflation anddeflation cycles up torated burst pressure1 ISO 105552 ISO 25539Standard test2BIOTRONIK test10 times20 times
“If there is no workerinvolvement, there is noquality system.”Lloyd Dobyns andClare Crawford-MasonUS authors
“The secret of greatness is simple: do better work than any other man inyour field - and keep on doing it.“Wilfried A. PetersonUS writer
Pinpoint accuracy,unmatched safetySetting the gold standard in electrophysiology.At BIOTRONIK, quality is not just part of the big picture, it is part ofthe smallest detail as well. From the first mapping catheter to today’ssophisticated gold-tip ablation catheters, BIOTRONIK continues tobreak new ground in electrophysiology. Each of our high-precisioncatheters is designed to optimize performance, control, and safety,ultimately leading to more successful treatments.Every catheter is fabricated to demanding specifications.Each year, more than 250,000 electrodes are fitted andsoldered with uncompromising accuracy.We use over 275,000 m of copper wire and 2.1 kg ofgold annually in catheter manufacturing, which iscontinuously monitored for precise mechanical andelectrical specifications.
From our hands to youQuality through and through.As an independent, privately held company, we believe the best way toretain superior quality is to stay in charge of the entire process. This is whyall of the critical components that go into our products are made by our ownhighly experienced manufacturers in both Germany and the U.S. From thesmallest component to the most sophisticated technologies, we control allparts of the process. It is just another level of trust and reliability we canoffer our customers.BIOTRONIK has established andwill sustain full ownership of andaccess to all mission-criticalfull ownershiptechnologies.
“There is no substitute for knowledge.”W. Edwards DemingUS management theorist
“Quality means doing it rightwhen no one is looking.”Henry FordUS industrialist
A long track recordof reliabilityThe proof is in the percentages.It is one thing to claim reliability. It is another to prove it. AtBIOTRONIK, that is just what we have been doing since ourcompany was founded in 1963. We view every customer asour only customer. And in return they have come to trust andrely on our long history of quality, reliability, and safety. Afterall, when it comes to our customers, reliability is nothing lessthan essential.Lumax ICD family: With more than100,000 implanted devices, we demonstratea reliability rate greater than 99.8%.630 million stimuliThe patient relies on 630 million pacemakerstimuli over a 10-year period.
Who we are at a glanceBIOTRONIK is one of the world‘s leading cardiovascular medical device companies providingcutting-edge solutions in the areas of cardiacrhythm management, electrophysiology, andvascular intervention. Priding ourselves onengineering excellence, we are representedin over 100 countries and have a global workforce of over 5,000 employees.
IndexSilicone injection molding toolShock coils, ICD leadsShock coil wiring, ICD leadsFormed balloonSelf-expanding stentCatheter ring electrodesCircuit boardActive fixation screws
Pacemaker shellsHome Monitoring antennaPacemakersLead wiresHome Monitoring antennaIodine, pacemaker batteryHeader casting, pacemakerFinal acceptance test, pacemaker
Welding protection ribbonAssembly tool, pacemakerBalloon-expandable stentsSelf-expanding stentAblation catheter tipsPart of the lead tipSilicon waferSubassembly, ICD
Lead coil manufacturingTest adapter, active implantsPrinted circuit board, pacemaker
375647/B/1005BIOTRONIK SE & Co. KGWoermannkehre 112359 Berlin · GermanyTel 49 (0) 30 68905-0Fax 49 (0) 30 6852804sales@biotronik.comwww.biotronik.com by BIOTRONIK SE & Co. KGAll rights reserved. Specificationsare subject to modification, revisionand improvement.
2000 Introduction of BIOTRONIK Home Monitoring 2003 First internet-based Home Monitoring system 2006 First bidirectional telemetry and IEGM-Online HD 2009 First intelligent traffi c light system First and only FDA and CE approved remote monitoring system to safely rep
