TOP Medical consists of a highly experienced, uniquely qualified team of experts, experienced in the assessment and commercialization of medical devices.

TOP Medical is ISO 13485:2016 Certified

About us

About us
About us

TOP Medical consists of a highly experienced, uniquely qualified team of experts, experienced in the assessment and commercialization of medical devices.

In 2003, TOP Medical was founded by Jan-Willem Hendriks and Annemieke van de Weyer with the aim to identify new and innovative medical device companies and introduce them to the European, and more specifically the Benelux market.

In the following years, the company refined its strategy with a view to address also the growing market need for Clinical Trial Services, Logistics and Sales & Marketing Consultancy.

Today, TOP Medical supports its customers in the various links of the chain from product idea to patient treatment, enabling new and break-through medical device technologies to enter the market timely and improve the quality of patient care.

This is accomplished by a team of qualified employees who respect the requirements and values of the medical environment.

Asahi Intecc, EPD Solutions, Shockwave Medical, Neovasc, Cameron Health, Direct Flow Medical, Invatec, Concentric Medical, ev3, Ablation Frontiers, Irvine Biomedical, CID, Velocimed, Werkmeister, Tryton Medical, and Toray chose TOP Medical to introduce their products in the Benelux countries.

TOP Medical is ISO 13485:2016 Certified by DEKRA

Our team

Sander Allon, Managing Director

Sander Allon,
Managing Director

Sander joined TOP Medical in March 2010. Before joining TOP Medical Sander obtained his Master of Science degree in Biomedical Engineering at the University of Eindhoven.

Xemina Boubegra, Sales & Marketing Director

Xemina Boubegra,
Sales & Marketing Director

Xemina started in June 2010 and holds a Bachelor degree in Social Work. Before joining TOP Medical Xemina worked in leading sales positions at Abbott and Astra Zeneca.

Annemieke van de Weijer, Co-Founder & Business Development

Annemieke van de Weijer,
Co-Founder & Business Development

Annemieke holds a Bachelor degree in Nursing and is active in the medical device industry since 1993. Fields of expertise are Sales, Marketing and Business Development. Annemieke launched several complex and disruptive technologies that got acquired.

Jan-Willem Hendriks, Co-Founder & Finance

Jan-Willem Hendriks,
Co-Founder & Finance

Jan-Willem holds a Bachelor degree in Business Economics and works in the medical device industry for more than 20 years. Fields of expertise are Sales, Finance and Operations. 

Diana Limón Alonzo, Sales & Clinical

Diana Limón Alonzo,
Sales & Clinical

Diana joined TOP Medical in December 2013. Before TOP Medical Diana obtained her Bachelor of Biomedical Engineering in Monterey Mexico and her Master of Science at the University of Twente.

Berit Robroch, Sales & Clinical

Berit Robroch,
Sales & Clinical

Berit joined TOP Medical in November 2015. Before TOP Medical Berit obtained her Bachelor of Biology and her Master of Science in Medical Biology at the University of Nijmegen.

Loïc van Aelst, Sales & Clinical

Loïc van Aelst,
Sales & Clinical

Loïc joined TOP Medical in October 2017. Before joining TOP Medical Loïc obtained his Master of Biomedical Engineering at the University of Leuven, Belgium.

Joren Maeremans, Sales & Clinical

Joren Maeremans,
Sales & Clinical

Joren started at TOP Medical on February 1st 2018. Before joining TOP Medical Joren obtained his Master of Biomedical Sciences at the University of Hasselt, Belgium. On January 18th, 2018 he defended his doctoral thesis entitled Percutaneous Coronary Intervention of Chronic Total Occlusions: Exploring the Final Frontier.

Antoinette Spierings, Quality Management Representative

Antoinette Spierings,
Quality Management Representative

As Quality Management Representative Antoinette is responsible for our ISO 13485:2016 Quality Management System. She is an expert in process control and improvement as required by the Medical Device Directives.

Vera Ploem, Operations Manager

Vera Ploem,
Operations Manager

Vera joined TOP Medical in 2013 after she obtained her Bachelor degree in Business Administration.

Joy Houben, Customer Service Representative

Joy Houben,
Customer Service Representative

Joy joined TOP Medical in 2018 after she obtained her Bachelor in Facility Management.


  • Interventional Cardiology
    Interventional Cardiology
  • Electrophysiology & CRM
    Electrophysiology & CRM
  • Transcatheter Valve Replacement
    Transcatheter Valve Replacement
  • Peripheral Interventions
    Peripheral Interventions
  • Intensive Care
    Intensive Care

Interventional Cardiology

Refractory Angina

  • Reducer, Neovasc

Intravascular Lithotripsy

  • IVL, Shockwave Medical

Coronary Stents

  • Cre8 EVO DES, Alvimedica

FFR Wires

  • Optowire, Opsens Medical

Coronary Guidewires

  • Sion Blue, Asahi Intecc
  • Sion Blue ES, Asahi Intecc
  • Sion, Asahi Intecc
  • Sion Black, Asahi Intecc
  • Fielder XTR, XTA, Asahi Intecc
  • Ultimate Bros, Asahi Intecc
  • Gaia First, Second, Third, Asahi Intecc
  • Confianza Pro 9, Pro 12, Asahi Intecc
  • RG3, Asahi Intecc
  • Suoh 03, Asahi Intecc
  • Extension, Asahi Intecc

Hybrid CTO Catheters

  • Corsair Pro, Asahi Intecc
  • Caravel, Asahi Intecc
  • Tornus, Asahi Intecc
  • Sasuke, Asahi Intecc


  • Sheathless, Asahi Intecc
  • Hyperion, Asahi Intecc


  • YOKA, Asahi Intecc

Pressure Bandage

  • Cosafix, Werkmeister

Electrophysiology & CRM


Transseptal Needles

  • NRG RF Needle, Baylis Medical

Transcatheter Valve Replacement

Percutaneous Transvenous Mitral Commisurotomy

  • Inoue-Balloon, Toray

Transseptal Needles

  • NRG RF Needle, Baylis Medical

Peripheral Interventions


  • Gladius, Asahi Intecc
  • Halberd, Asahi Intecc
  • Gaia PV, Asahi Intecc
  • Regalia, Asahi Intecc
  • Treasure, Asahi Intecc
  • Astato, Asahi Intecc




Intensive Care

Blood Filters

  • Seraph 100 Microbind Affinity Blood Filter, ExThera Medical





Sales & Marketing

Sales & Marketing

Beside product distribution TOP Medical consults for several medical device companies to support them with their European Sales & Marketing activities.

Training & Education

Training & Education

TOP Medical has the capability to organize educational workshops and congresses. 

Logistics & Customer Service

Logistics & Customer Service

TOP Medical supports external companies with their logistics, device accountability, customer service, invoicing and account receivables.

ExThera Medical Commences Commercial EU Sales of the Seraph® 100 Blood Filter

ExThera Medical Commences Commercial EU Sales of the Seraph® 100 Blood Filter

Maastricht, January 13th, 2020

ExThera Medical Commences Commercial EU Sales of the Seraph® 100 Blood Filter, a Treatment for Drug-Resistant Bloodstream Infections
Martinez, Calif. – January 10, 2020 – ExThera Medical has commenced commercial sales in the European Union (EU) of its revolutionary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) by establishing strategic distributors in Italy, Germany, and the Benelux countries.
In October, soon after receiving CE Mark approval in late July 2019, over 100 devices were shipped to Europe. The first post-CE Mark clinical treatment occurred in November 2019, with promising results.  ExThera is now preparing for increased sales in anticipation of positive early results. “This is a monumental step in the company’s history” says Dr. Keith McCrea, Vice President Research & Development/CSO of ExThera Medical. “We look forward to more clinical results to be presented in upcoming medical congresses, in published case studies, and from our large company-sponsored Post Market Study”.
In 2019, ExThera established three new partnerships with TOP Medical, Burke & Burke, and Heinz Meise GmbH for exclusive distribution rights in Benelux, Italy and Germany, respectively.  Agreements were signed shortly after ExThera’s CE Mark approval of Seraph 100 for the broad indication of pathogen reduction during bloodstream infections (BSI) in adjunction with antibiotic therapy.
With a shared interest in bringing breakthrough medical technology to patients in need, these commercial partners, TOP Medical, Burke & Burke and Heinz Meise GmbH have worked closely with ExThera  to introduce a revolutionary therapy to address bloodstream infections, which affect over 1 million people in Europe every year.
The Seraph 100 blood filter provides a new option for treating bloodstream infections with its unique technology. Whereas, existing hemoperfusion devices remove only molecules, the Seraph 100 can also quickly lower the concentration of bacteria, viruses and fungi in whole blood.  In pre-clinical and clinical testing, Seraph 100 was able to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance.
“We are excited to work with TOP Medical, Burke & Burke and Heinz Meise GmbH to bring Seraph to important EU countries. These organizations have long, established commitments to offering healthcare providers and patients quality options, and we’re happy to support their efforts to address a serious, global medical need,” commented Bob Ward, NAE President/CEO of ExThera Medical.
Headquartered in Maastricht, The Netherlands and founded in 2003, TOP Medical has a strong track record enabling new and breakthrough medical device technologies to enter the Benelux market to improve the quality of patient care. TOP Medical is ISO 13485:2016 certified.
Burke & Burke SpA is a private company established in 1967 with headquarters in Assago–Milan, and several regional offices throughout the country.  They are a leader in ICU and NICU with a presence in all Italian hospitals and are recognized for their ability to introduce innovative Intensive Care products.
Heinz Meise GmbH Medizintechnik is based in Nordrheinwestfalen Germany and was established in 1983. The company, which is ISO 13485 certified, develops, manufactures and distributes sterile disposables and devices for acute dialysis, apheresis and transfusion medicine.
Additional distribution partnerships will be announced in 2020.
About the Seraph® 100 Microbind® Affinity Blood Filter
As a patient's blood flows through the Seraph, it passes over spheres coated with molecular receptor sites that mimic the receptors on human cells that pathogens use when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface and are thereby reduced in concentration in the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells intact. The adsorption media is a flexible platform using chemically bound, immobilized heparin for its blood compatibility, and its unique capacity to bind a long list of pathogens.
About ExThera Medical
Based in Martinez, California, and in Vaals, The Netherlands, ExThera is a privately held medical device company developing innovative, single-use blood filters capable of capturing a broad range of bacteria, viruses, parasites, toxins or other harmful substances from whole blood. The company develops therapeutic products to treat patients in the hospital or clinic, during epidemics, or on the battlefield. Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has strong patent protection and a growing body of data from independent laboratory studies, from its participation in DARPA’s Dialysis-Like Therapeutics program and from a successful EU clinical trial.
For more information, visit
Disclaimer: All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release. Seraph is not approved for use by the FDA.


TOP Medical Training & Education Center celebrates 3rd anniversary

TOP Medical Training & Education Center celebrates 3rd anniversary

Maastricht, January 2nd, 2020

TOP Medical Training & Educations Center opened in january 2017 and up to today we trained 74 Physicians and 232 Nurses from 37 Benelux hospitals. In case you like to receive more information about the different workshops please contact your local Product Specialist or sent a message to

TOP Medical signs exclusive distribution agreement with Shockwave Medical

TOP Medical signs exclusive distribution agreement with Shockwave Medical

Maastricht, October 10th, 2018

TOP Medical signed an exclusive distribution agreement with Shockwave Medical for the distribution of its IVL Technology in the Benelux countries. Shockwaves IVL Technology integrates the calcium disrupting power of lithotripsy with the familiarity and simplicity of balloon-based interventional devices. Built on a traditional balloon catheter platform, IVL Devices use the intermittent pulsatile mechanical energy of lithotripsy to disrupt calcium while minimizing soft tissue injury and an integrated balloon to dilate lesions, restoring blood flow. Please contact our Product Specialist or visit our Training & Education Center to learn more about this innovative technology.

TOP Medical ISO 13485:2016 certified by DEKRA

TOP Medical ISO 13485:2016 certified by DEKRA

Maastricht, July 1st, 2018

We are very proud that TOP Medical is ISO 13485:2016 Certified by DEKRA for the Sales and distribution of active, non-active, implantable and non-implantable medical devices.


TOP Medical celebrates 15th anniversary

TOP Medical celebrates 15th anniversary

Maastricht, June 13th, 2018

On June 13th 2003 TOP Medical was founded with the aim to identify new and innovative medical device technologies and introduce them to the European, and more specifically the Benelux market. 

Today, on June 13th 2018, we celebrate our 15th anniversary and we are proud that we have been involved in the launch and adoption of many new and break-through medical device technologies. This is accomplished by a team of qualified employees who respect the requirements and values of the medical device environment. 

We like to thank our Customers, Business Partners and Employees for the achievements in the last 15 years. It has been a privilege to work with you in order to improve the quality of patient care. 

Annemieke & Jan-Willem

Philips acquires EPD Solutions

Philips acquires EPD Solutions

Elsloo, June 5th, 2018


Amsterdam, the Netherlands - Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced that it has signed an agreement to acquire EPD Solutions, an innovator in image-guided procedures for cardiac arrhythmias (heart rhythm disorders). EPD’s cardiac imaging and navigation system [1] helps electrophysiologists navigate the heart by generating a detailed 3D image of the cardiac anatomy, while also pinpointing the location and orientation of catheters during the diagnostic and therapeutic procedures for cardiac arrhythmias. This breakthrough technology has the potential to simplify navigation and treatment, immediately assess the treatment result and ultimately enhance procedure efficacy. 

The acquisition will complement Philips’ portfolio of interventional imaging systems, smart catheters, planning and navigation software, and services, and will allow the company to introduce new solutions in the EUR 2+ billion market [2] for image-guided treatment of cardiac arrhythmias, which is growing at a double-digit rate. Philips will acquire EPD for an upfront cash consideration of EUR 250 million and deferred, milestone dependent payments. In connection with these contingent payments, the company expects to recognize a provision of approximately EUR 210 million [3] upon completion of the transaction. The transaction, which is subject to customary closing conditions, is expected to be completed in July, 2018. .

“EPD’s breakthrough innovation provides detailed 3D anatomical information of the heart during cardiac arrhythmia ablation procedures that is unique in the industry,” said Frans van Houten, CEO of Royal Philips. “The technology has the potential to address the key unmet need of real-time therapy assessment, which is one of the more significant limitations of the current standard of care. This acquisition will strengthen our ability to improve the lives of arrhythmia patients, and is entirely consistent with our strategic plan to broaden our image-guided therapy solutions portfolio and drive long-term profitable growth for Philips.”

“I am very pleased that Philips will become the home for our innovation, our business and our people,” said Professor Shlomo Ben-Haim, Founder and Chairman of EPD Solutions. “Philips’ expertise and leadership in interventional imaging and navigation is an excellent strategic fit with EPD. I am convinced that as part of Philips, we will be able to grow EPD and help many electrophysiologists and patients worldwide, as we aim to reduce procedure costs, simplify navigation and treatment, and ultimately improve procedure efficacy.”

The combination of Philips’ interventional imaging systems, such as Azurion, and EPD’s cardiac imaging and navigation system provides the maps and data used by electrophysiologists to guide various catheters to locate and treat cardiac arrhythmias. EPD’s system, which obtained CE marking in February, 2018, is based on proprietary software algorithms and single-use electromagnetic sensors, used in conjunction with standard electrophysiology catheters. The system has been installed at several leading hospitals across Europe. The premarket notification (510(k)) for the system for imaging and navigation during arrhythmia ablation procedures is currently under review by the US FDA.

Upon completion of the transaction, EPD and its employees will become part of Philips’ Image-Guided Therapy business. Professor Shlomo Ben-Haim, who has a proven track record in building successful medical device businesses, will continue to support Philips to build a new business based on this acquisition.

[1]     EPD’s cardiac imaging and navigation system is not available for sale in the US.

[2]     Addressable market for Philips. Following the acquisition of EPD, Philips’ total addressable Image-Guided Therapy market is EUR 8+ billion.

[3]     Estimated fair value of the contingent payments.

Corsair Pro from Asahi Intecc is now available in the Benelux

Corsair Pro from Asahi Intecc is now available in the Benelux

Maastricht, April 25th, 2017

After a higly succesfull introduction of the Caravel microcatheter we are very proud to announce that we will launch another innovative technology from Asahi Intecc; Corsair Pro

The Corsair Pro is the latest innovation in the field of microcatheters specially developed by Asahi Intecc for the treatment of CTO's. By minimizing the stiffness difference between the tip and the shaft, Corsair Pro will be able to track tortuous vessels, which improves its ability to cross challenging anatomies. The hydrophilic coating optimizes catheter performance and crossing ability in tortuous anatomy and complex lesions. The 60cm hydrophilic coating of Corsair Pro is optimized to balance backup support and catheter crossing performance.

For more information please contact your local TOP Medical Sales Representative or sent an email to


Third Amsterdam CTO Symposium will take place on November 30 - December 1 2017

Third Amsterdam CTO Symposium will take place on November 30 - December 1 2017

Amsterdam, April 15th, 2017

TOP Medical is pleased to invite Interventional Cardiologists for the third Amsterdam CTO Symposium which will take place on November 30 and December 1 2017 in the VU Medical Center in Amsterdam. (The registration is closed since October 15th, 2017 because we reached the maximum number of 175 participants)


TOP Medical opens Training & Education CentreTOP Medical opens Training & Education Centre

TOP Medical opens Training & Education Centre

Maastricht, January 2nd, 2017

TOP Medical Consultancy B.V. is proud to announce that it opened its Training & Education Centre at its facility in Elsloo-Maastricht.

From today we offer FFR, Guidewire, Antegrade- and Retrograde CTO Workshops.

Our CTO workshop is for example an introduction to Antegrade & Retrograde CTOs for Cardiologists and Cath-lab teams. This workshop will include hands-on and a detailed slides explaining: Hybrid Approach algorithm, Hybrid strategies, Anatomical factors determination, Proximal Cap, CTO length, Distal Cap, Degree of disease in distal zone, Quality of Interventional collaterals.

Retrograde fundamentals in 10 steps:

  1. Planning
  2. Collateral Analysis
  3. Collateral Cannulation
  4. Advancing Microcatheter
  5. Collateral wire crossing
  6. Collateral Microcatheter crossing
  7. Equipment to distal CTO Cap
  8. Lesion Crossing
  9. Externalization
  10. Stenting the CTO

We conclude this workshop with a hands on training in different CTO models.

In case you have an interest to join one of our workshops please contact

Courtesy of Vascular Perspective

Opsens announces first use of its FFR products in Europe

Opsens announces first use of its FFR products in Europe

Elsloo, January 12th, 2015


Quebec City, Quebec, January 12, 2015 – Opsens Inc. (“Opsens”) (TSXV:OPS) is pleased to announce the first use of its Fractional Flow Reserve (“FFR”) products in Europe by the “founding fathers” of FFR, namely Dr. Bernard De Bruyne at the Cardiovascular Center Aalst, Belgium and, shortly, by Professor Nico Pijls, at  the Catharina Hospital, Eindhoven the Netherlands. The OptoWire and OptoMonitor are Opsens’ products for FFR measurements to optimize the diagnosis and guide the therapy in patients with coronary heart disease.

"The arrival of an optical FFR guidewire such as the OptoWire on the market is positive for interventional cardiologists who need to obtain reliable FFR measurements. It was a pleasure to use the OptoWire in several patients, some of them with complex disease. It allowed me to appreciate its impressive zero drift performance during all cases performed while also acknowledging the constant connection reliability as well as its support during percutaneous coronary intervention", said Dr. Bernard De Bruyne from the Cardiovascular Center Aalst.

"Dr. Pijls and De Bruyne collaborated extensively to establish FFR as the gold standard in the evaluation of coronary lesions. Consequently, we are proud seeing Dr. De Bruyne, one of the most globally recognized cardiologists and an investigator in the FAME clinical studies on FFR, using our products in practice. Opsens already obtained regulatory approvals for Japan and Europe. We are now entering our commercial phase with a controlled launch with several institutions in Europe and Japan." said Louis Laflamme, President and CEO of Opsens.

Opsens aims at becoming a key player in the guidewire FFR market with the OptoWire, a nitinol-based optical guidewire for FFR. The OptoWire provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire delivering optimized performances to navigate coronary arteries and reach blockages with ease. Based on industry sources, the FFR market represented over US$250 million in sales in 2013 and is expected to reach US$1 billion in the medium-term. Opsens is confident that it is well positioned to capitalize on this significant growth opportunity.

About Opsens Inc. (

Opsens focuses mainly on two large and growing markets: interventional cardiology with a focus on Fractional Flow Reserve ("FFR") and the oil and gas and industrial industry. In interventional cardiology, Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Opsens also develops, manufactures and installs innovative fibre optic sensing solutions for critical applications such as the monitoring of oil wells and other demanding industrial applications.

Tryton Medical Announces First Results from Pivotal Study

Tryton Medical Announces First Results from Pivotal Study

Elsloo, June 9th, 2014

Tryton Medical Announces First Results From Pivotal Study of the Tryton Side Branch Stent™

Presented at TCT 2013 Annual Meeting in Late Breaking Clinical Trial Session October 30, 2013 01:25 PM Eastern Daylight Time SAN FRANCISCO--

Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced the first results from the Tryton Side Branch Stent Pivotal IDE trial were presented during a Late Breaking Clinical Trial session at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The Tryton Pivotal IDE trial is an international, randomized study that compares a Tryton Side Branch Stent to conventional provisional treatment (balloon angioplasty) in the side branch, with both study groups receiving a standard drug eluting stent (DES) in the main vessel. The study, which is the first randomized FDA IDE pivotal clinical trial to evaluate a dedicated bifurcation stent, enrolled 704 patients at 67 centers in North America and 11 countries throughout Europe and Israel. It is the largest coronary bifurcation study ever conducted and the first study to employ core lab angiographic (3D and planar) and IVUS analysis.

Key findings from the study include:

• Both the Tryton strategy and the provisional strategy appeared to be safe, with rare clinical post procedure myocardial infarctions, low rates of stent thrombosis, and no cardiac death. Both study arms had low 9-month clinically driven target vessel revascularization, or TVR (Tryton 4.7%; Provisional 3.6%).

• Tryton, compared to the provisional arm of the study, did not meet the non-inferiority clinical endpoint of target vessel failure (TVF)1, driven in large part by peri-procedural CK-MB elevations (Tryton 17.4%; Provisional 12.8%). Sixty percent of the side branch vessels treated were smaller than the intended study population of side branch vessels of 2.25 mm diameter or greater by QCA.

• Tryton, compared to the provisional arm of the study, demonstrated superiority in reducing percent diameter side branch stenosis (Tryton 31.6%; Provisional 38.6%; p=.002), the powered secondary endpoint.

• Post hoc subgroup analysis of the intended study population demonstrated Tryton out performed the provisional arm of the study in TVF (Tryton 11.3%, Provisional 15.6%) as well as reduced percent diameter stenosis (Tryton 30.4%; Provisional 40.6%; p=.004).

Martin B. Leon, M.D., F.A.C.C., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, and founder and chairman emeritus of the Cardiovascular Research Foundation, serves as principal investigator of the study. The Tryton Pivotal IDE trial is a first of its kind, landmark study that has provided high-quality data and will inform the treatment of bifurcation disease worldwide for years to come, said Dr. Leon. Tryton represents an important option when treating complex bifurcations. I congratulate the study investigators, and thank them for their work. Donald E. Cutlip, M.D., Executive Director of Clinical Investigations at Harvard Clinical Research Institute, stated The post hoc analysis strongly supports a benefit for the Tryton Stent in the intended population. The results are hypothesis generating, to be supported by further analysis.

The Tryton Stent is supported by robust clinical evidence in more than 1,000 patients. Published data in a patient pooled analysis from more than 900 patients treated with the Tryton Stent in more than 8 European post-marketing registries demonstrated low target lesion revascularization rates of 2.9 percent at six months and 4.0 percent at one year, and a low 0.5 percent thrombosis rate at one year.

The findings from the Tryton IDE trial confirm my personal experience with the Tryton Stent over the past five years. The Tryton Stent enables me to treat high risk bifurcation lesions in a controlled fashion with superb result, said Maciej Lesiak, M.D., Ph.D., chief of the catheterization laboratory at the Karol Marcinkowski University of Medical Sciences, Poznan, Poland. Dr. Lesiak enrolled 37 patients in the Tryton Pivotal IDE trial. When I’m treating patients with complex bifurcations, the Tryton Stent is the preferred treatment option. Safely and effectively treating bifurcation disease in a controlled manner remains a significant unmet need in cardiovascular care. Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. In the patients each year that undergo PCI-stenting annually, approximately one-third have a bifurcation lesion. We are pleased with the performance of the Tryton Stent overall in the study, especially in the population it was designed to treat, said Shawn P. McCarthy, president and CEO of Tryton Medical. This is another wave of compelling clinical evidence supporting use of the Tryton Stent, bringing us one step closer to introducing this technology to the US market. The data also validate our international experience, which includes more than 8,000 patients treated with the Tryton Stent throughout Europe, Russia and the Middle East.”

About the Tryton Side Branch Stent System The Tryton Side Branch Stent System is built for bifurcation 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.

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) and Dan Cole, General Partner at Spray Ventures. Privately held, Tryton is backed by PTV Sciences, RiverVest Venture Partners, Spray Venture Partners, and the 3x5 Special Opportunity Fund. For more information please visit and follow the company on Twitter at @TrytonMedical1.

Demonstr8 Randomized Trial Shows Excellent Results For Cre8 Drug Eluting Stent

Demonstr8 Randomized Trial Shows Excellent Results For Cre8 Drug Eluting Stent

Paris, May 30th, 2013

CID released the results of the Demonst8 randomised trial results at the EuroPCR. The study, presented by principal investigator Francesco Prati, showed that the Cre8 drug-eluting stent was non-inferior to a bare metal stent with a high statistically significant difference (RUTTS Score <30%; 99,75% Cre8 vs 99,55% BMS; (p<0.0001). data-cke-saved-src= src=

The study rationale was to assess if strut coverage at three months of the polymer-free Cre8 drug-eluting stent, once it becomes bare metal sent after complete drug-elution, is equivalent to a standard bare metal sent, such as the Abbott Vascular Vision, in patients with coronary artery disease.

According to a company press release, with the findings of the study, it is now possible to assess if Cre8 could allow three months’ dual antiplatelet therapy duration—since at this point of time it has become a bare metal stent and its endothelisation is comparable to a standard bare metal stent (for which the guidelines recommend one month month’s dual antiplatelet therapy).

The study has also shown that the drug-eluting stent was superior to the bare metal stent in terms of neointima thickness, even if the optical coherence tomography measurement was assessed at three months for Cre8 vs. one month for the bare metal stent. The press released reported that this confirms that the safety features of Cre8 have been proven without any impact on device efficacy (neointima thickness; 0.08mm Cre8 vs.0.18mm BMS; p<0.0001).

At the end of the presentation, Prati commented: “The perfect, regular and thin coverage seen for Cre8 in the Demonstr8 trial, coupled with the unique abluminal reservoir technology empowered by the bioInducer surface and the lack of any polymer, makes it the only drug-eluting stent able to safely interface with blood and vessel as a standard bare metal stent after only three months. This sets a new benchmark in safety profile for a drug-eluting stent.”

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