TOP Medical consists of a highly experienced, uniquely qualified team of experts, experienced in the assessment and commercialization of medical devices.
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.
Direct Flow Medical, Asahi Intecc, Cameron Health, Invatec, Concentric Medical, ev3, Ablation Frontiers, Irvine Biomedical, CID, Velocimed, Tryton Medical, and Kimberly Clark chose TOP Medical to introduce their products in the Benelux countries.
TOP Medical is ISO 13485:2003 Compliant.
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. She launched several complex and disruptive technologies that got acquired.
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. He co-founded several companies where he optimized processes to establish profitability.
Kees has 15 years of experience in the medical device industry and joined TOP Medical in October 2011. Before TOP Medical, Kees worked for Medtronic in different leadership roles. Fields of expertise are Sales and Account Management.
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. Sander is an expert in Electrophysiology, Cardiac Rhythm Management and Transcatheter Aortic Valve Replacement.
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. Xemina is an expert in Transcatheter Aortic Valve Replacement and Peripheral Interventions.
Ilse joined TOP Medical in november 2013. Before TOP Medical Ilse worked as registered nurse in the ZNA hospital in Antwerp and as Product Specialist at MSD and Tigenix. Ilse is an expert in Interventional Cardiology with Chronic Total Occlusions in particular.
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. Diana is an expert in Transcatheter Aortic Valve Replacement and Interventional Cardiology.
Antoinette joined TOP Medical in 2012. As Quality Management Representative Antoinette is responsible for our ISO 13485:2003 Quality Management System. She is an expert in process control and improvement as required by the Medical Directives.
Indra joined TOP Medical on August 30th, 2010 and studied Business Communication and Modern Languages. Indra has a broad experience in supporting Management Teams and is an expert in the communication with our Business Partners.
Ralph joined TOP Medical in 2005, Vera and Danny in 2012. They are experts in serving our customers and are 24/7 available for urgent requests. THEY CARE!
Transcatheter Aortic Valve Replacement
Precutaneous Transvenous Mitral Commisurotomy
Hybrid CTO Catheters
Remote Patient Monitoring
Cooled RF Therapies
Beside product distribution TOP Medical consults for several medical device companies to support them with their European Sales & Marketing activities.
Because of an extensive and reliable network TOP Medical has access to highly qualified medical professionals, hospitals and research departments.
TOP Medical supports external companies with their logistics, device accountability, customer service, invoicing and account receivables.
DIRECT FLOW MEDICAL® TRANSCATHETER AORTIC VALVE SYSTEM DEMONSTRATES EXCELLENT 12 MONTH OUTCOMES IN DISCOVER CE MARK TRIAL
SANTA ROSA, Calif. and PARIS, France – May 22, 2014 – Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced 12 month outcomes from the DISCOVER CE Mark Trial. In the trial, a 90 percent survival rate was reported, continuing the initial positive trend of 99 percent survival after 30 days. Patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System and experienced excellent overall hemodynamic results, as well as a low rate of procedural complications. At 12 months, 100 percent of patients experienced mild or less aortic regurgitation (AR), with 77 percent having none or trace AR. The DISCOVER Trial 12 month outcomes were presented today by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany.
The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at high or extreme surgical risk, while reducing the risk of post-procedural AR, a strong predictor of long-term mortality. The system addresses this clinical concern by sealing the annulus and enabling complete assessment of hemodynamic performance with unlimited repositioning of the valve after full deployment. It avoids both rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic instability for patients. The system includes a distinctive heart valve with a metal-free frame, delivered transfemorally via a flexible, 18 French delivery system for all sizes (23mm, 25mm, 27mm and 29mm).
In the DISCOVER Trial, the mean transthoracic echo gradient at 30 days was 12.5mmHg and remained low at 12 months (12.3mmHg). All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory. The VARC Defined Device Success rate was 91 percent. At 30 days, 83 percent of patients had improved by more than one New York Heart Association (NYHA) functional class and this was maintained at 12 months, with 95 percent classified as NYHA Class I/II.
“The 12 month DISCOVER results are unprecedented for a TAVI device,” said Professor Schofer. “The Direct Flow Medical system has demonstrated that it successfully treats aortic stenosis with low mortality, while at the same time addressing the very serious issue of aortic regurgitation in a clinically meaningful way in order to significantly improve patient outcomes.”
The initial DISCOVER Trial was a prospective, multicenter study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. The trial has since expanded to additional sites and patients, enrolling patients in 23mm valve and 29mm valve trial arms. The 29mm valve received CE Mark in December 2013 and the 23mm valve is pending CE Mark approval.
The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.
About The Direct Flow Medical System
The benefits of the Direct Flow Medical Transcatheter Aortic Valve System are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the Direct Flow Medical System incorporates a polymer frame, which is expanded using pressurized saline and contrast for placement, assessment and repositioning. The saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place once optimal positioning is reached. The unique double-ring design of the valve creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The metal-free design enables a low-profile (18 French), fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.
Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing patient complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The Company’s proprietary technology is not limited to aortic valve disease, and is readily applicable to mitral and other heart valve anatomical sites. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at www.directflowmedical.com.About Direct Flow Medical, Inc.
TOP Medical signs distribution agreement with Myelotec
We are pleased to announce that TOP Medical has signed an exclusive distribution agreement with Myelotec, the leading company for epiduroscopy, adhesiolysis and targeted administration of epidural medication. Herewith we have expanded our portfolio with minimal invasive solutions for the treatment of spine related chronic pain.
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 2014, we celebrate our 11th 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 are committed to continue with our mission and expand our business model to more European countries.
We like to thank our Customers, Business Partners and Employees for the achievements in the last 11 years. It has been a privilege to work with you in order to improve the quality of patient care.
Jan-Willem & Annemieke
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.
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.”