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 & MDR Proof

ABOUT US

ABOUT USABOUT US
ABOUT USABOUT US

TOP Medical brings together skilled, experienced, and qualified experts to drive the assessment and commercialization of promising medical devices, with a focus on the the fields of interventional cardiology, electrophysiology, and peripheral interventions.

We are convinced that the potential of new, innovative medical technologies is too often left unexploited. By selecting technologies that strongly attribute to a better experience for both patient and physician, we support innovative medical companies throughout the process from idea conceptualization to patient treatment. In this way, our team introduces outstanding break-through medical devices to Benelux hospitals, enabling them to further raise healthcare to unprecedented levels of excellence.

The philosophy of TOP Medical is to improve the quality of patient care through targeted product training and specialized assistance before, during and after procedures, with respect for the deontological 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.

Valérie Snoeijs, Sales & Clinical

Valérie Snoeijs,
Sales & Clinical

Valerie joined TOP Medical in November 2020. Before joining TOP Medical Valerie obtained her Master of Biomedical Engineering at the University of Leuven, Belgium.

Mijntje de Leeuw, Sales & Clinical

Mijntje de Leeuw,
Sales & Clinical

Mijntje joined TOP Medical in May 2022. Before she started her career at TOP Medical, Mijntje got her diploma and has been active in nursing.

PRODUCTS

Neovasc

  • Reducer System

QXMédical

  • Boosting Guide Extension Catheter

Asahi Intecc

  • Hyperion
  • SheathLess Eaucath Guiding Catheter

Shockwave Medical

  • Coronary C2 IVL Balloon Catheter

Alvimedica

  • Cre8 EVO Polymer Free DES

Asahi Intecc

  • Sion Series
  • Grand Slam
  • Fielder Series
  • Gladius EX
  • Gladius MG
  • UltimateBros
  • Gaia Series
  • Confianza Pro Series
  • Miraclebros Series
  • SUOH 03
  • RG3
  • Extension
  • Silverway 0.035” Diagnostic

Asahi Intecc

  • Corsair Pro
  • Corsair Pro XS
  • Caravel
  • Sasuke
  • Tornus

Asahi Intecc

  • OKAY II

Werkmeister

  • Cosafix

Baylis Medical

  • NRG RF Transseptal Needle

Toray Medical

  • Inoue-Balloon

Shockwave Medical

  • Peripheral M5 IVL Balloon Catheter
  • Peripheral S4 IVL Balloon Catheter

Asahi Intecc

  • Gladius
  • Gladius MG PV
  • Gaia PV
  • Halberd
  • Astato
  • Regalia
  • Treasure
  • Silverway 0.035" Diagnostic

Werkmeister

  • Cosafix

TRAINING & EDUCATION

TOP Medical personalized training and proctorship programs support physicians and allied health professionals to master complex and CTO interventions in the field of Interventional Cardiology and Radiology. 

Our training courses have been designed in partnership with local keyopinion leaders to secure clinical safety and simplify medical insights to educate your entire team.  
 
Using high-end educational presentations, recorded cases and product simulation workstations, we provide your team with the opportunity to gain an in-depth understanding of the various product technologies, applications and techniques. 
 
We offer a variety of training and education opportunities at our Training & Education Centre near Maastricht, The Netherlands, or on site. 
 
Annually we welcome teams from all Benelux hospitals and have had the privilege to share a meaningful and motivating educational experience.

SIGN-UP FOR YOUR EDUCATIONAL EXPERIENCE
Contact your TOP Medical Representative or contact us at info@top-medical.com.

TOP Medical's general guidewire courses provide your team with an understanding of the construction, performance, and various applications of guidewires. 

  • Guide Wire Technology | Basics 
  • Coronary Pressure Assessment

Together with local experts, we explored various topics within complex PCI by defining anatomical and procedural challenges and how to overcome them. The training courses include an educational presentation, supported by case examples and hands-on simulations.

  • Complex Bifurcation 
  • Tortuous Vessels 
  • Calcified Lesions 
  • Aorto-Ostial Lesions 
  • Intravascular Lithotripsy Technology

To stay up to speed with the skills and tools needed to master the CTO PCI routine, we offer CTO training days for the entire team. Supported by a simulation training course, which provides the unique opportunity to experiment risk-free with tools and techniques to resolve difficulties that may arise during a procedure.

  • Chronic Total Occlusion | Basics
  • Chronic Total Occlusion | Toolbox

TOP Medical's courses provide your team with an understanding of device construction, performance and various applications of different technologies.

  • Guide Wire Technology 
  • Intravascular Lithotripsy Technology
TOP Medical Training & Education Center celebrates 5th anniversary

TOP Medical Training & Education Center celebrates 5th anniversary

Maastricht, May 19th, 2022

TOP Medical Training & Educations Center opened in january 2017 and up to today we trained 154 Physicians and 362 Nurses from 43 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 administration@top-medical.com.

TOP Medical ISO 13485:2016 Certified & MDR Proof

TOP Medical ISO 13485:2016 Certified & MDR Proof

Maastricht, January 1st, 2022

We are very proud that TOP Medical passed the ISO 13485:2016 renewal audit for the Sales and distribution of active, non-active, implantable and non-implantable medical devices. We implemented the new MDR regulations in our QMS and are MDR-Proof!

 

TOP Medical signs exclusive agreement with QX Medical

TOP Medical signs exclusive agreement with QX Medical

Maastricht, August 4th, 2020

We are proud to announce that TOP Medical signed an exclusive agreement for the distribution of the Boosting Catheter in the Benelux. The QXMédical Boosting Catheter is the next generation guide extension support catheter for use with guiding catheters and sheaths to assist delivery and exchange of interventional devices in coronary and peripheral vessels. The catheter offers exceptional trackability along with a novel tip design and large internal passageways to facilitate complex procedures.

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. customerservice@top-medical.com

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 info@top-medical.com.

 

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 administration@top-medical.com

Courtesy of Vascular Perspective

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 www.trytonmedical.com 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).
 

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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