Medinol announces excellent clinical results for EluNIR™, a novel Drug Eluting Stent

Wednesday, December 21, 2016

PARSIPPANY, N.J., Dec. 21, 2016 /PRNewswire-USNewswire/ -- Medinol, a global Interventional Cardiology device company, announced excellent twelve month clinical results from the BIONICS study.  The study was conducted to evaluate EluNIR™, Medinol's novel coronary stent system and the first ever elastomer coated drug eluting stent (eDES™). This global pivotal study enrolled 1,919 patients from 76 sites in 8 countries. The BIONICS results were highlighted in the opening Late Breaking Trial session of the 28th annual Transcatheter Cardiovascular Therapeutics (TCT2016) scientific symposium in Washington DC. The study data will be submitted to the FDA to support the U.S. regulatory approval of EluNIR for the treatment of patients with narrowing or blockage of their coronary arteries.

The BIONICS study, a global, prospective, randomized, multicenter, non-inferiority clinical trial was designed to include a "more comers" population, i.e. one that closely represents the real-world patient population. The EluNIR Stent (study name BioNIR™) was compared to the Resolute Integrity™ Stent (1:1 randomization). Key results from the study include:

  • For its primary endpoint, Target Lesion Failure (TLF), EluNIR demonstrated a rate of 5.4% at 12 months compared to an identical rate of 5.4% for Resolute (p=0.0013 for non-inferiority). TLF was defined as the composite of cardiac death, target vessel MI, and clinically driven TLR.
  • Good safety profile, with a low definite/probable stent thrombosis rate of 0.4% for EluNIR, compared to 0.8% for Resolute (p=NS) with no events beyond 30 days for EluNIR.    

"The BIONICS data validated that the EluNIR stent performed very well in a more broad, less selected 'more comers' population than has previously been studied for most other DES," said David Kandzari, M.D., F.A.C.C., Director of Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA and principal investigator for the BIONICS trial. "These results establish the excellent clinical performance of this stent, and we look forward to seeing the angiographic data over the next few months to further support its efficacy."

In addition to the BIONICS study, new twelve-month data from NIREUS, the European pivotal trial for EluNIR, were presented at TCT. The NIREUS study, a prospective, multi-center, randomized, non-inferiority pivotal study comparing EluNIR to the Resolute Integrity Stent, met its non-inferiority primary end point of angiographic in-stent late loss at 6 months. These data were presented at EuroPCR in May 2016. The recent twelve-month clinical data, presented TLF of 3.4% for EluNIR and 5.9% for Resolute (p=NS). These outcomes were consistent with the positive results of BIONICS. 

"The BIONICS data are consistent with the excellent results that were demonstrated by EluNIR in NIREUS," said Dr. Yoram Richter, Chief Scientific Officer of Medinol. "In the U.S. alone over 700,000 patients undergo a coronary stenting procedure each year. We are excited to be able to provide them with a new treatment option that has proven outstanding clinical results."

EluNIR is different from other drug eluting stents based on several key traits.  EluNIR is coated with an elastomer that maintains a smooth and uniform surface designed to prevent the pro-inflammatory cracking or peeling that may occur with brittle polymers. Furthermore, Medinol manufactures and coats the stent in flat panels utilizing its patented QualitySurface™ technology, ensuring quality, consistency and control over the coating and elution characteristics. EluNIR is coated with ridaforolimus, a "limus" family drug which is intended to prevent restenosis. The stent's design is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength. The delivery system is unique, featuring a distinctive spring tip that is simultaneously more pushable and flexible than the conventional plastic tips used on other delivery systems. EluNIR is currently an investigational device and is not available for commercial sale.

Further information about the EluNIR Stent and the BIONICS trial can be found on the Medinol website. 

About Medinol
Medinol LTD, headquartered in Israel, with U.S. Commercial offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, its in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, a bare metal stent called NIRxcell™. With over two million stents deployed to date, Medinol's cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation.  For more information go to www.medinol.com.

 

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Medinol Receives Approval from The Japanese PMDA to Begin Clinical Study on Novel DES

Tuesday, November 8, 2016

PARSIPPANY, N.J. - Nov. 7, 2016 - Medinol, a developer of Interventional Cardiology devices, announces the receipt of a Clinical Trial Notification (CTN) from the Pharmaceutical and Medical Devices Agency (PMDA) in Japan to initiate its regulatory approval study for EluNIR™ Stent System (known as BioNIR™ in the study), a novel elastomeric Drug Eluting Stent.  The study, named JNIR, is designed to confirm the safety and efficacy of EluNIR in the Japanese clinical environment. The expected enrollment will be 100 patients and the results will be added to those from the patients already enrolled in BIONICS, the EluNIR Pivotal Study for FDA clearance.

"This is excellent news for interventional cardiologists in Japan.  The unique design features of Medinol's Drug Eluting Stent System are extremely promising. We are hopeful that the JNIR trial will enable access for cardiology patients to the safest and most efficacious treatment to date," said Dr. Shigeru Saito, MD, FACC, FSCAI, FJCC, FAPSIC, Director of Cardiology & Catheterization Laboratories and Vice President of Shonan Kamakura General Hospital and the Primary Investigator for JNIR.

 

The BIONICS clinical trial is a 1:1 randomized study comparing the EluNIR Stent System to Medtronic's Resolute Integrity™ Stent System and has enrolled 1,919 patients in the U.S., EU, Canada and Israel. The primary endpoint of the study is target lesion failure (TLF), determined at 12 months after the procedure.  The twelve month clinical results were presented at TCT 2016 in the opening Late Breaking Trials session on October 30th, and it was announced that EluNIR met its primary endpoint and demonstrated TLF rates of 5.3% compared to 5.3% for Resolute (p=0.0012 for non-inferiority).  More details about the BIONICS results are available here.  The data will be submitted to the FDA for U.S. approval of EluNIR for the treatment of patients with narrowing or blockage of their coronary arteries. 

 

"Medinol strives to develop innovative products that solve complicated cardiovascular problems, and the EluNIR Stent System is a prime example," said Dr. Yoram Richter PhD, Chief Scientific Officer of Medinol. "We believe that it will serve as a significant advancement in patient treatment options based on stent and elastomer coating design improvements and overall deliverability.  Medinol is excited to introduce EluNIR in Japan so that even more patients around the world will benefit from its technology." 

 

There are several aspects of the EluNIR stent that differentiate it from other products currently available.  EluNIR is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the cracking or peeling that may occur with brittle polymers used in other DES. The stent is comprised of cobalt chromium and manufactured and coated in flat panels utilizing Medinol's patented QualitySurface™ Technology and contains the drug Ridaforolimus, a Rapamycin analog, intended to prevent restenosis. The EluNIR design is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength.  The delivery system is unique, featuring a distinctive spring tip that is simultaneously more pushable and flexible than conventional plastic tips used on other delivery systems. EluNIR is an investigational device and is not available for commercial sale.

 

Read more on the EluNIR clinical program

Study Finds Medinol's Ridaforolimus-Eluting Stent Is Non-Inferior to Zotarolimus-Eluting Stent Based On One-Year Clinical Outcomes

WASHINGTON – October 30, 2016 – The large multinational randomized BIONICS study found that a novel ridaforolimus-eluting stent (BioNIR) was non-inferior to a zotarolimus-eluting stent (Resolute) for one-year clinical outcomes in a broad, less selected ‘more comers’ population. Results of this trial will be submitted to the FDA for U.S. approval of this novel drug-eluting stent.

Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

The ridaforolimus-eluting stent is a thin-strut (90 µm) cobalt chromium stent that elutes the rapamycin analogue ridaforolimus from a durable elastomeric polymeric coating. The multicenter randomized trial was conducted at 76 medical centers in the U.S., Canada, Europe, and Israel and enrolled a broad range of patients with coronary artery disease including patients with Non-ST Elevation MI (NSTEMI) as well as complex lesions. The primary endpoint was target lesion failure (TLF) at one year, the composite rate of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia driven target lesion revascularization (ID-TLR). Secondary endpoints were one year major adverse cardiovascular events (MACE), target vessel failure (TVF) and individual component endpoints, definite/probable stent thrombosis and procedural success.

A total of 1,919 patients were randomized 1:1 to the BioNIR ridaforolimus-eluting stent (n= 958, 1,275 lesions) or Resolute zotarolimus-eluting stent (n=961, 1,277 lesions) stent. The baseline clinical characteristics were well balanced between the two arms, as were angiographic baseline characteristics with the exception of severe calcification (13.3% in the BioNIR group vs. 10.5% in the Resolute group, P=0.03).

The primary endpoint of TLF at one year was identical for both at 5.3% (P=0.98). In addition, the rates of cardiac death (0.5% vs. 0.2%, P=0.29), TV-MI (3.1% vs. 3.3%, P=0.81) and ID-TLR (3.0% vs. 2.4%, P=0.38) were similar. Definite/probable stent thrombosis was 0.4% (4/921) for the ridaforolimus-eluting stent

and 0.6% (6/927) for the zotarolimus-eluting stent (P=0.75). Device success was 98.3% for the ridaforolimus-eluting compared to 99.5% for the zotarolimus-eluting stent (P=0.004).

“One-year clinical outcomes from the BIONICS study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates,” said principal investigator, David E. Kandzari, MD. Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at the Piedmont Heart Institute in Atlanta, GA. “In addition, it had a low stent thrombosis rate with no events beyond 30 days.”

The BIONICS trial was funded by Medinol and designed and conducted by the CRF Clinical Trials Center in collaboration with Novella Clinical which provided site management. Dr. Kandzari reported grant or research support from Abbott Vascular, Boston Scientific, Medtronic, Biotronik, St. Jude Medical/Thoratec, and Ablative Solutions, and consulting fees/honoraria from Boston Scientific, Medtronic, Micell Technologies, and St. Jude Medical.

The results of the BIONICS Trial were presented on Sunday, October 30th in the in the opening session of Late Breaking Trials at TCT2016.

 

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

 

Read the Press Release at the CRF Website

 

Medinol Announces Outstanding Results in a Randomized Trial of a New Drug Eluting Stent

Tuesday, May 17, 2016

PARSIPPANY, N.J. and TEL AVIV, Israel, May 17, 2016. Medinol announced outstanding results from the NIREUS trial for BioNIR™, its new coronary stent system and the first ever elastomeric Drug Eluting Stent or eDES™. NIREUS is a prospective, multi center, randomized, non-inferiority pivotal study comparing Medinol's BioNIR to the Resolute Integrity™ Stent. The study enrolled 302 patients with coronary artery disease at 31 sites in Europe and Israel and will be used to support Medinol's submission for CE mark.

NIREUS met its non-inferiority primary end point of angiographic in-stent late loss at 6 months. The BioNIR stent has demonstrated an exceptionally low late loss result of 0.04+/-0.31 mm (N=201) compared with 0.03+/-0.31 mm for Resolute Integrity (N=101) with a high degree of statistical significance (p<0.0001). In addition, the BioNIR stent demonstrated a Target Lesion Failure rate of 1.5% at 6 months compared with 3.0% for Resolute Integrity (p=NS). The results were unveiled during the EuroPCR 2016 conference in Paris.

"We are very enthusiastic about the NIREUS results, particularly with the remarkably low in-stent late loss. These uncommonly good clinical results will help increase physician confidence in the long term benefits of the BioNIR stent for patients," said Pieter C. Smits, MD, PhD, at Maasstad Ziekenhuis, Rotterdam, The Netherlands, principal investigator for the NIREUS trial. Dr. Smits further commented on the BioNIR stent's angiographic appearance: "The stent conforms well to the vessel, and provides consistent, smooth scaffolding.  This is all very exciting, and we look forward to following these patients to see how these excellent outcomes progress over time."

"The BioNIR stent is innovative in the way it is made, as well as in its use of novel elastomeric materials," said Dr. Yoram Richter, Chief Scientific Officer of Medinol. "Together, these ensure that the coating maintains its long-term integrity and uniform surface, through expansion and drug elution. This has the effect of lowering inflammation and distributing a controlled and uniform dose of drug to the vessel wall."

BioNIR is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength while the delivery system features a distinctive spring tip that is simultaneously more pushable and flexible than the plastic tips used on other stent delivery systems. The stent is comprised of cobalt-chromium and elutes ridafarolimus, a "limus" family drug, intended to prevent restenosis. It is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the pro-inflammatory cracking and peeling that occurs with brittle polymers used in other drug eluting stents. The BioNIR Stent System is an investigational device and is not available for commercial sale.

About Medinol 
Medinol Ltd., headquartered in Israel, with US offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, our in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, the NIRxcell™ bare metal stent. With over two million stents deployed to date, Medinol's cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and its products constantly stretch the limits of innovation. For more information go to www.medinol.com

NIRTRAKS Study of a Novel Coronary Stent Enrolls its First Patient

Monday, March 21, 2016

PARSIPPANY, N.J., - Medinol is pleased to announce the enrollment of their first patient in the U.S. NIRTRAKS Study. NIRTRAKS is a post marketing, non-randomized study of the NIRxcell™ Stent System in patients with coronary artery disease indicated for PCI.  The study objective is to collect and analyze additional information about the safety and effectiveness of the NIRxcell stent in the treatment of de novo lesions in native coronary arteries in the U.S. population. The data will be collected from 131 patients with a primary endpoint of target vessel failure (TVF) at 3 years.  Dr. Manesh Patel, Duke University Hospital, is the national PI for the study with a total of eight sites participating across the U.S.  “We are pleased with the start of the NIRTRAKS study, allowing us to gather further data on this unique and highly innovative technology.  While we have been utilizing the NIRxcell commercially for the last nine months, we are excited to further understand the clinical application this new design has for our patients,” said Dr. Patel, Duke University Hospital.

The first patient was enrolled into the study on January 15, and over the last few weeks, site enrollment has continued to increase. Medinol’s Chief Scientific Officer, Yoram Richter, PhD describes the importance of this surveillance study, “We are excited to have the first NIRxcell stents implanted in the NIRTRAKS study.  We believe that the NIRxcell bare metal stent, with its advanced cell design and its spring tipped delivery system, is uniquely different from other available products. In PIONIR, a previous prospective study, the stent demonstrated exceptional clinical outcomes including a 5.1% TLR rate at 9 months. We are eager to get further confirmation from interventional cardiologists on the advantages that NIRxcell can offer to their patients”.  

The NIRxcell Stent is Medinol's fifth generation coronary stent. It features the unique WiZeCell™ stent design, offering an optimal balance between vessel conformability, scaffolding integrity and radial strength.  The Flexx2™ delivery system with a spring tip ensures ease of delivery even in the most tortuous and calcified anatomies.  NIRxcell became commercially available in the U.S. in January 2015, and in a short period of time found its way into 40+ large hospitals across the country. NIRxcell Stent technology serves as a platform for Medinol’s eDES™ (elastomer drug-eluting stent) currently in clinical trials in the U.S., Canada, Europe and Israel.

 

About Medinol

Medinol, headquartered in Israel, with U.S. Commercial offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention.  For over 20 years, Medinol's in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. With over two million stents deployed to date, their cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation.  For more information go to www.medinol.com

 

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Medinol U.S. Commercializes Novel Coronary Stent

Tuesday, December 1, 2015

PARSIPPANY, N.J., - During the recent 2015 Transcatheter Cardiovascular Therapeutics Meeting held in San Francisco, CA, Medinol Ltd. continued to introduce novel stent solutions to the coronary marketplace. During a satellite symposium, "The BioNIR eDES: The Role of Uniformity in Stent Design to Minimize Restenosis", a renowned physician panel discussed the key attributes of the currently available Medinol NIRxcell™ CoCr Coronary Stent System and the Medinol eDES Coronary Stent System (in trials, not FDA/CE Mark approved).  Physician faculty included David E. Kandzari, MD – Piedmont Heart Institute, Jim Zidar, MD – North Carolina Heart and Vascular, Rajiv Jauhar, MD – North Shore University Medical Center, Peter Smits, MD – Maasstad Ziekenhuis, Rotterdam, the Netherlands and Shmuel Banai, MD – The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.  Discussion highlighted key product features and emphasized the unique design of the BIONICS/NIREUS clinical trials that have recently completed enrollment.  Dr. Kandzari commented, "The delivery system is unlike any other product on the market" and Medinol's approach to trial design "was entirely unlike any other pivotal trial as it included a 'more comers' patient population."

Medinol U.S. recently opened their commercial business in Parsippany, NJ followed by the launch of NIRxcell CoCr Stent System.  Matt Donnelly – U.S. General Manager commented, "Our goal is to provide optimal solutions for patient treatments through innovative product designs, novel and efficient manufacturing processes and robust clinical data.  We believe that this is a winning combination to drive a product portfolio that will offer value to patients, physicians and healthcare facilities."

On an annual basis, approximately 800,000 patients undergo coronary stenting procedures in the US. Healthcare providers continue to look for novel, effective and efficient solutions to treat their patients, leaving room for new entrants with innovative products to enter the market. Medinol has been at the forefront of innovation for years, and thus is well positioned to deliver an optimal portfolio to the marketplace beginning with the introduction of their NIRxcell CoCr Stent System.  In an interview, Marty Leon, MD – Director of the Center for Interventional Vascular Therapy at New York-Presbyterian/ Columbia University Medical Center stated "We will never stop innovating and Medinol has been a prototype company that has been synonymous with continuous innovation."  Following link (http://www.medinol.com/?video=1) will allow you to hear Dr. Leon's actual interview, including his thoughts on the ongoing development needs within the coronary stent marketplace.

About Medinol
Medinol LTD, headquartered in Israel with U.S. commercial offices in Parsippany, NJ, is dedicated to the science of cardiovascular intervention.  For over 20 years, in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, a bare metal stent called NIRxcell™.  With over two million stents deployed to date, their cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation. For more information go to www.medinol.com.

 

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Medinol Completes Enrollment in Randomized, Multicenter, Pivotal Study of eDES™ Coronary Stent System

Tuesday, September 22, 2015

PARSIPPANY, N.J., - Medinol, a developer of Interventional Cardiology devices, announced today the completion of enrollment in its BIONICS trial, a global, prospective, randomized, multicenter, clinical trial designed to evaluate the safety and effectiveness of a new Coronary Stent System, the first ever elastomeric Drug Eluting Stent or eDESTM.    The BIONICS trial enrolled 1,918 patients in the U.S., EU, Canada and Israel and the results will be submitted to the FDA for the U.S. approval of the eDES for the treatment of patients with narrowing or blockage of their coronary arteries.

There are several aspects of this stent that differentiate it from other products currently available.  The eDES is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the cracking or peeling that may occur with brittle polymers used in other DES during the stent crimping and deployment processes.  The stent is comprised of cobalt chromium and manufactured and coated in flat panels utilizing Medinol’s patented QualitySurfaceTM Technology and contains a “limus” family drug, intended to prevent restenosis. The eDES design is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength.  The delivery system is unique as well, featuring a distinctive spring tip that is simultaneously more pushable and flexible than the plastic tips used on other delivery systems. 

“The design of eDES enhances stent deliverability and conformability for the treatment of complex coronary disease. The system is unique from other products currently being offered, and will be a great addition to our current treatment options." said David Kandzari, M.D., F.A.C.C., Director of Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA and principal investigator for the BIONICS trial. Additionally, Dr Kandzari was impressed with several aspects of the study, that proved to be ground-breaking, and very different from past DES clinical trials, "One of the distinctive aspects of the study is how inclusive the enrollment criteria is, allowing for almost all patient populations to be included in the study, and making it very relevant to the populations we see in our practices today.  We look forward to getting the results after follow up."

The BIONICS clinical trial is a 1:1 randomized study comparing the eDES System to Medtronic’s Resolute Integrity™ Stent System. The primary endpoint of the study is target lesion failure (TLF) as determined at 12 months.   The eDES System is an investigational device and is not available for commercial sale.

 “Medinol has been dedicated to the development of products to improve the quality of life for patients for years.  We have spent a lot of time studying coronary vasculature and have focused our efforts on product designs that ‘respect the vessels’ through both conformability and scaffolding,” said Dr. Judith Richter, CEO of Medinol.  “We believe that our innovative eDES will offer a significant advancement in patient treatment options based on stent and elastomer coating design improvements and overall deliverability.” 

More information about BIONICS and the eDES will be presented at TCT 2015 in San Francisco on Wednesday October 14th at a satellite breakfast symposium entitled, “The BioNIR eDES: The Role of Uniformity in Stent Design to Minimize Restenosis.”  Registration information is contained here.

 About Medinol

Medinol LTD, headquartered in Israel, with U.S. Commercial offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention.  For over 20 years, in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, a bare metal stent called NIRxcell™.  With over two million stents deployed to date, their cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation.  For more information go to www.medinol.com

 

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