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 13485:2003 Certified
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, Neovasc, Cameron Health, 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 13485:2003 Certified by DEKRA
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.
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.
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.
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.
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.
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.
Jody joined TOP Medical in 2015 and supports the Sales and Clinical Team.
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
Percutaneous Transvenous Mitral Commisurotomy
Hybrid CTO Catheters
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.
SANTA ROSA, Calif.– March 28, 2016 – Direct Flow Medical, Inc., a medical device company developing and commercializing transcatheter heart valve therapy products to treat structural heart disease, today announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.
The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.
The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. “I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery” stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”
“We’re pleased to provide physicians with this latest advance in TAVI procedural control” stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, “The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”
About Direct Flow Medical, Inc.
Direct Flow Medical, Inc. is a privately-held medical device company developing and commercializing novel transcatheter heart valve therapy products to treat structural heart disease.
The company is sponsoring the SALUS Pivotal Trial in the U.S. to investigate the Direct Flow Medical Transcatheter Aortic Valve System for treatment of high and extreme risk severe symptomatic aortic stenosis. The system is commercially available in Europe for treatment of patients with aortic stenosis who are at extreme surgical risk.
Company website: directflowmedical.com
We are very proud that TOP Medical is ISO 13485:2003 Certified by DEKRA for the Sales and distribution of active, non-active, implantable and non-implantable medical devices.
TOP Medical is pleased to announce that it signed an exclusive agreement for the distribution of the XTEND radial arm board and XTEND left elbow support device in the Benelux countries.
The XTEND right radial arm board and left elbow support device are designed to properly position patient's right and left arm to any angle during a radial procedure to optimize the comfort for the patient and cardiologist.
For more information please contact us a firstname.lastname@example.org.
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 2015, we celebrate our 12th 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 12 years. It has been a privilege to work with you in order to improve the quality of patient care.
Annemieke & Jan-Willem
TOP Medical is pleased to announce that it has signed an exclusive distribution agreement with Rapid Medical for the Comaneci and Pele device.
Rapid Medical's mission is to develop safe and effective neurovascular medical devices that are beneficial to patients and meet physicians' needs. They are committed to advancing patient care by providing the most reliable, easiest to use and highest quality products supported by proven clinical data. Rapid Medical is located at the northern part of Israel between the Carmel Mountain and the hills of Ramot Menashe.
On behalf of Dr. Knaapen, Dr. Nap, Dr. Kinoshita and Asahi Intecc TOP Medical is pleased to invite Interventional Cardiologists for the first Amsterdam CTO Symposium which will take place on November 19-20, 2015 in the VU Medical Center in Amsterdam. For more information please open the attached Amsterdam CTO Symposium flyer. Interventional Cardiologists can register via email@example.com.
We are pleased to post the following article which is written in the dutch language:
Eerste "nieuwe" aortaklep met succes ingebracht in Aalst en Dendermonde Auteur: Belga
"Vernauwing van de aortaklep treedt meer op bij een verouderende bevolking en leidt zonder behandeling tot overlijden", zegt dokter Michaël Rosseel (ASZ Aalst). "Sinds enkele jaren bestaat de mogelijkheid om deze klep percutaan (zonder operatie) te behandelen door via de lies een nieuwe klep in te brengen. In België werden een twaalftal centra erkend voor deze techniek. Daarbij ook het ASZ.
Samen met het AZ Sint Blasius Dendermonde werden in januari voor het eerst in ons land twee patiënten behandeld met een klep van de nieuwe generatie, de Direct Flow Medical Valve. "De twee patiënten werden onder een oppervlakkige verdoving behandeld en konden reeds na vier dagen het ziekenhuis in prima toestand verlaten."
De hartklep van kunststof heeft enkele voordelen tegenover een metalen stent, onder meer bij de plaatsing en evaluatie. "Het design zorgt voor een optimale afdichting, zodat terugstroming van het bloed vermeden wordt. Anders dan de gebruikelijke metalen systemen in België is het systeem volledig herpositioneerbaar en kan het zelfs worden teruggehaald bij een suboptimaal resultaat. Dit resulteert in een verbeterde levenskwaliteit en overleving." Ondanks de niet-terugbetaling ervan in België, nam het ASZ de klep op in zijn programma en rekent het geen kosten aan voor de patiënt.
Opsens ANNOUNCES FIRST USE OF ITS FFR PRODUCTS IN EUROPE WITH DR DE BRUYNE
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. (www.opsens.com)
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.
SANTA ROSA, Calif., October 1, 2014 – Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has received the CE Mark (Conformité Européenne) for an enhanced transfemoral delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.
The enhanced Direct Flow Medical delivery system offers an ergonomic handle designed for easy, precise and controlled delivery of the Direct Flow Medical valve. The system features a low profile, ultra-flexible sheath that, in addition to the non-metallic valve, allows for easy access and excellent trackability through calcified and tortuous anatomies. All of the Direct Flow Medical valves can be delivered through the same, low profile and flexible delivery system.
The Direct Flow Medical valve features a unique, double-ring design that conforms to the anatomy and creates a tight and durable seal around the annulus. The valves allow for complete assessment of hemodynamic performance and unlimited repositioning until optimal results are obtained. The company now has a valve portfolio that includes 23mm, 25mm, 27mm and 29mm valves, which can treat patients with annulus sizes from 19mm to 28mm.
“Direct Flow Medical continues to innovate with the focus on improving patient outcomes. The approval of the enhanced Direct Flow Medical delivery system is further evidence of our commitment to the medical community that treats TAVI patients,” said Direct Flow Medical Chief Medical Officer Charles Davidson, M.D. “We continue to deliver on our promise to develop innovative products delivering the best patient outcomes, and continue to investigate new indications for our unique therapeutic platform.”
The Direct Flow Medical valve is designed to improve TAVI outcomes by virtually eliminating aortic regurgitation, offering unlimited repositionability during the procedure and reducing overall complications.
“We have been able to access vessels as small as 5.2mm with the Direct Flow Medical delivery system. The system is very flexible and tracks very well in highly calcified anatomies,” said Christoph Naber, M.D. from the Contilia Heart and Vascular Center in Essen, Germany. “The newly approved system offers enhanced precision and improved control for valve delivery while being extremely simple to use.”
The Direct Flow Medical Transcatheter Aortic Valve System is commercially available in Europe. In the U.S., the company is progressing towards regulatory approval and is currently enrolling patients in its SALUS pivotal trial.
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 system avoids rapid pacing of the heart during deployment, and does not require post-dilatation following placement. The Direct Flow Medical Transcatheter Aortic Valve System is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR).The metal-free design enables a low-profile, fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.
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.
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.”