Zilver PTXBoston ScientificCoronary stentsVascularPeripheralBiliary StentLesionsPaclitaxel-CoatedDose of paclitaxelSuperficial2018Dual antiplatelet therapyBare metalDAPTRestenosis2016GraftIliacPolymerOutcomesSystemInterventionVersusPatientsBalloonComparableVesselVesselsDeviceMedicalDevicesTechnologyReleaseLower
Zilver PTX12
- Also presented at the meeting was a 24-month analysis of data from the IMPERIAL Trial, which evaluated the Eluvia stent versus the Zilver PTX Drug-eluting Peripheral Stent for the treatment of patients with symptomatic PAD that had SFA and PPA lesions up to 140 mm in length. (dicardiology.com)
- In the study, the Eluvia stent exhibited a primary patency rate of 83% versus 77.1% with Zilver PTX, by Kaplan Meier estimate, the highest 24-month primary patency reported to date for the treatment of femoropopliteal disease in a U.S. pivotal trial with a DCB or DES. (dicardiology.com)
- A low all-cause mortality rate of 7.1% for the Eluvia stent and 8.3% for those treated with the Zilver PTX (p=0.6649), which is within range expected for symptomatic peripheral arterial disease. (dicardiology.com)
- The Eluvia drug-eluting vascular stent system (Boston Scientific) shows superior primary patency compared to the Zilver PTX drug-eluting stent (Cook Medical), concludes the 12-month. (vascularnews.com)
- The IMPERIAL trial was a prospective, randomised, single-blinded, multicentre global study aimed at comparing the effectiveness and safety of the Eluvia with Zilver PTX for treatment of symptomatic femoropopliteal artery lesions (lesion length 30-140mm, Rutherford category 2-4). (vascularnews.com)
- For instance, the Eluvia stent had a target lesion revascularisation rate of 4.5%, in contrast to 9% observed within the Zilver PTX cohort. (vascularnews.com)
- Additionally, the Eluvia stent was found to be more effective than the Zilver PTX, with a primary vessel patency of 88.5% at 12-months versus 79.5% after the same time-frame. (vascularnews.com)
- Both the Eluvia stent system and the Zilver PTX-which are designed to restore blood flow in the superficial femoral and proximal popliteal arteries-feature a drug-polymer combination intended to allow for the sustained release of paclitaxel. (vascularnews.com)
- The Zilver PTX drug-eluting stent also has a wealth of strong clinical data supporting its efficacy. (vascularnews.com)
- Five-years results from the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease, published in 2014, evidenced long-term patency for patients treated with the Zilver PTX. (vascularnews.com)
- This 2014 study compared the Zilver PTX with a bare metal stent, and confirmed the "sustained benefit" of the paclitaxel-eluting stent. (vascularnews.com)
- A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. (cardiologynownews.org)
Boston Scientific5
- Boston Scientific received FDA approval to introduce its Innova vascular stent in the United States for treating narrowing or occlusions within the superficial femoral or proximal popliteal arteries. (medgadget.com)
- November 6, 2019 - Boston Scientific announced positive data for two of its devices within the peripheral drug-eluting product portfolio during separate late-breaking clinical trial presentations at Vascular Interventional Advances (VIVA) meeting in Las Vegas. (dicardiology.com)
- We are very pleased with the safety and efficacy demonstrated by the Ranger DCB and the Eluvia stent, both of which showed exceptional durability while preventing repeat TLRs in 66% and 40 percent of treated patients, respectively," said Ian Meredith, M.D. , executive vice president and global chief medical officer, Boston Scientific. (dicardiology.com)
- The combination of the RANGER DCB as well as the Eluvia stent positions Boston Scientific as the only company to have both a DES and a DCB for the treatment of PAD in their portfolio. (dicardiology.com)
- M.I.Tech is the creator of the HANAROSTENT technology, a family of conformable, non-vascular, self-expanding metal stents, which have been distributed by Boston Scientific in. (vascularnews.com)
Coronary stents1
Vascular7
- Presented results from the MAJESTIC trial at the 37th Charing Cross International Symposium demonstrating the Eluvia™ Drug-Eluting Vascular Stent System + met its primary safety and effectiveness endpoints, with more than 94 percent of lesions treated remaining open at nine months post implantation. (prnewswire.com)
- Epic™ Vascular Self-Expanding Stent System Ideal for the Iliac: The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. (acecardiopathy.com)
- The Innova Stent System is designed to provide a precise, predictable experience for vascular interventionalists. (acecardiopathy.com)
- Data presented included a 12-month interim analysis from the RANGER II SFA Trial of the Ranger Drug-coated Balloon (DCB), and the 24-month results from the IMPERIAL Trial of the Eluvia Drug-eluting Vascular Stent (DES). (dicardiology.com)
- We continue to drive innovation in the drug-eluting vascular space and these results add to the growing body of evidence supporting our therapy options for the treatment of this challenging disease. (dicardiology.com)
- This channel includes news and new technology innovations for stents, also called vascular scaffolds. (dicardiology.com)
- His current projects include the use of drug eluting technology in cardiovascular disease and cellular based therapy in peripheral vascular disease. (universitymedicalimagingtoronto.ca)
Peripheral8
- Entered into an agreement with C. R. Bard, Inc., to distribute the Lutonix® Drug Coated Balloon in the U.S. for the treatment of peripheral artery disease. (prnewswire.com)
- The Eluvia Stent System is designed to restore blood flow in the peripheral arteries above the knee - specifically the superficial femoral artery and proximal popliteal artery. (bostonscientific.com)
- The RANGER II SFA study evaluated the safety and effectiveness of the Ranger DCB, which has a low drug dose density of paclitaxel, versus standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). (dicardiology.com)
- The Eluvia stent utilizes a drug-polymer combination and offers controlled delivery and sustained release of the lowest dose of paclitaxel of any peripheral drug-eluting device. (dicardiology.com)
- For the treatment of peripheral arterial disease, drug-eluting technology is a widely accepted therapeutic option, with significant reduction in intimal hyperplasia and, consequently, use of target lesion revascularization. (bvsalud.org)
- Launched a line extension of the ELUVIA™ Drug-Eluting Stent (DES) , introducing the longest-length DES (150 mm) available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA). (pressreach.com)
- The Serranator PTA serration balloon catheter is the first and only angioplasty balloon to receive Food and Drug Administration (FDA) approval and the CE Mark that embeds serration technology into a semi-compliant balloon for treating peripheral arterial disease (PAD). (vascularspecialistonline.com)
- The results of a real-world safety analysis showed that over a follow-up period of up to 11 years, there was no evidence of increased mortality in patients who underwent endovascular revascularization of peripheral vessels with paclitaxel-based drug-eluting devices (DED). (cardiologynownews.org)
Biliary Stent1
- Express™ LD Iliac and Biliary Premounted Stent System Only Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability-without trade-off. (acecardiopathy.com)
Lesions1
- IMPERIAL: Slow-Eluting Stent Outpaces Standard for Fem-Pop Lesions Although the randomized head-to-head results for the investigational Eluvia stent were broadly welcomed in a field described as having a plethora of therapies but a paucity of data, caveats were raised. (medscape.com)
Paclitaxel-Coated1
- The results of a systematic review and meta-analysis of randomized controlled trials conducted by Konstantinos Katsanos and his colleagues have showcased an increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. (cardiologynownews.org)
Dose of paclitaxel1
- However, the presence of a polymer (a biostable fluorinated polymer matrix) contained within the Eluvia stent allows for a lower dose of paclitaxel, which is indicative of the main difference between the two stents. (vascularnews.com)
Superficial4
- The nitinol self-expanding bare stent is the foundation of the Eluvia drug-eluting stent designed specifically for the superficial femoral artery. (medgadget.com)
- Pulsar-18 is the only available self-expanding stent for blocked superficial. (vascularnews.com)
- Based on these findings, we believe that the Eluvia stent can be a preferred therapy option when treating patients with arterial blockages in the superficial femoral or proximal popliteal arteries. (vascularnews.com)
- In 2009, the device was the first CE mark-approved drug-eluting stent designed specifically to treat severe blockages in the superficial femoral artery. (vascularnews.com)
20182
- Nevertheless, the reputation of such devices was damaged after a meta-analysis, published in December 2018, showed increased mortality in patients receiving paclitaxel-eluting devices. (bvsalud.org)
- Mitchell Krucoff, MD (Duke University Medical Center, Durham, NC), who presented the results today in a late-breaking trial session at TCT 2018, told TCTMD that the stent should be approved for use in high-bleeding-risk patients. (tctmd.com)
Dual antiplatelet therapy1
- Evaluation of a polymer-free coronary drug-eluting stent in high bleeding-risk patients with one-month dual antiplatelet therapy. (tctmd.com)
Bare metal8
- DES require antiplatelet therapy because the drug carrier polymer on DES can cause thrombus inside the stent, even years after treatment, which is why bare metal stents are still used in some patients. (dicardiology.com)
- Also, Krucoff emphasized, "in American practice, some centers are still putting bare-metal stents in double digit numbers. (tctmd.com)
- Our intuitive behavior in the practice of putting bare-metal stents into patients for whom we know are at high bleeding risk, so we're only going to treat them for 30 days with DAPT, is actually a safety signal. (tctmd.com)
- I think that particularly when this stent becomes available, there's no question that it is more efficacious and safer than bare-metal stents," he commented. (tctmd.com)
- So it should replace bare-metal stents in these high-bleeding-risk patients, which ostensibly is why physicians are using them. (tctmd.com)
- Even though people say we should stop using bare-metal stents, we haven't. (tctmd.com)
- I think the single take-home message from the two BioFreedom studies is that if a bare-metal stent is what you were thinking of using and you have a drug-coated stent, use that, because it's safer and better. (tctmd.com)
- Because of that, "I think if we had this stent available in the United States with these data, we would stop using bare-metal stents. (tctmd.com)
DAPT2
- Received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the WATCHMAN™ FLX Left Atrial Appendage Closure (LAAC) Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation. (pressreach.com)
- I think bringing this stent forward with a label for 30 days [of DAPT] when we treat our patients is a yes. (tctmd.com)
Restenosis4
- Drug eluting stents (DES) are coated in anti-proliferative drugs to precent scar tissue growth which can cause restenosis and occlude the vessel. (dicardiology.com)
- This drug can prevent restenosis of the vessel. (vascularnews.com)
- These impressive clinical outcomes suggest that sustained elution of paclitaxel, delivered by the Eluvia stent, better matched the timing of restenosis in the SFA that can occur months later, thereby reducing the need for repeat interventions," said William Gray, co-principal investigator of the IMPERIAL trial. (vascularnews.com)
- Completed enrollment in the AGENT IDE trial, a prospective, multi-center, randomized study evaluating the safety and effectiveness of the AGENT™ Drug Coated Balloon for the treatment of patients with coronary artery disease who experience in-stent restenosis. (pressreach.com)
20161
- Off the back of data from the MAJESTIC trial, which evidenced long-term freedom from revascularisation at three years, the Eluvia stent system received the CE mark in early 2016. (vascularnews.com)
Graft1
- AVeVA study confirms benefit of covered stent placement in graft-vein anastomotic. (vascularnews.com)
Iliac1
- Dynetic-35, the balloon-expandable cobalt chromium iliac stent system from Biotronik, is now commercially available in Europe. (vascularnews.com)
Polymer2
- Eluvia provides consistent, durable outcomes in challenging SFA disease and features a polymer design for controlled drug release. (acecardiopathy.com)
- SAN DIEGO, CA-Compared with BMS, a polymer-free, drug-coated stent shows superiority at 1 year in terms of safety and efficacy among patients at high risk for bleeding, according to results of the LEADERS FREE II trial. (tctmd.com)
Outcomes1
- Backed by multiple Level-1 Randomized Controlled Trials, Ranger provides exceptional outcomes, effortless deliverability, and efficient drug transfer. (vitaminschannel.com)
System3
- We are also excited about bringing new innovation to patients with the recent Food and Drug Administration approvals of the WATCHMAN™ Left Atrial Appendage Closure Device and the EMBLEM™ Subcutaneous Implantable Defibrillator System. (prnewswire.com)
- Augmented the Endoscopy portfolio, with the launch of the next generation SPYGLASS ™ DS Direct Visualization System for advanced diagnosis and treatment of pancreatico-biliary diseases, and the acquisition of the Xlumena, Inc. stent delivery systems intended for endoscopic ultrasound (EUS) guided transluminal drainage of targeted areas within the gastrointestinal tract. (prnewswire.com)
- CONCLUSIONS: The Astron stent system was shown to be safe and effective in the treatment of patients with atherosclerotic disease. (universitymedicalimagingtoronto.ca)
Intervention1
- This new stent is designed to assist interventional cardiologists treat patients with coronary artery disease (CAD) with small vessels that are often untreatable with larger stent technologies during percutaneous coronary intervention (PCI). (idataresearch.com)
Versus1
- demonstrated that the superiority of Drug-Coated Balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in the efficacy of femoropopliteal artery disease (FPAD) treatment persists at 24-month follow-up. (cardiologynownews.org)
Patients4
- The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit-risk balance. (regulatoryrapporteur.org)
- Likewise, David Cohen, MD (Saint Luke's Mid America Heart Institute, Kansas City, MO), told TCTMD that he would be interested in having this stent as another option for his patients at high risk for bleeding. (tctmd.com)
- Future data might show that "the current drug-eluting stents are fine and better for those patients, but [for] that one we don't know the answer," Cohen continued. (tctmd.com)
- TCT 2019 Zero-Contrast PCI in CKD Patients Helps Avoid Later Dialysis No coronary lesion seemed too complex for the procedure that used intravascular ultrasound and pressure readings to guide stenting, usually avoiding need for contrast injection, protecting the kidneys. (medscape.com)
Balloon1
- Stents are used to help prop open a vessel treated by balloon angioplasty because of the barotrauma caused by the extreme stretching of vessel walls. (dicardiology.com)
Vessel1
- The stent enables to vessel to heal in an open position with collapsing. (dicardiology.com)
Vessels1
- Designed specifically for small vessels, Medtronic announced the FDA approval and U.S. launch of the Resolute Onyx(TM) 2.0 mm Drug-Eluting Stent (DES), the smallest sized DES on the market. (idataresearch.com)
Device3
- Received Food and Drug Administration (FDA) approval of the WATCHMAN ™ Left Atrial Appendage Closure Device and completed first U.S. procedures. (prnewswire.com)
- The RANGER DCB gained European CE mark in 2014 and the company submitted for U.S. Food and Drug Administration (FDA) approval of the device earlier this year. (dicardiology.com)
- Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device. (vascularnews.com)
Medical1
- Speaking with TCTMD, Sunil Rao, MD (Duke University Medical Center, Durham, NC), said this needs to be reduced and a stent like BioFreedom could help with that. (tctmd.com)
Devices1
- Although subsequent studies have failed to establish such correlation, the use of paclitaxel-eluting devices remains heavily restricted. (bvsalud.org)
Technology1
- In this article we present the available data on drug-eluting technology. (bvsalud.org)
Release1
- Getinge has announced the full US market release of the Pulsar-18 stent from Biotronik. (vascularnews.com)
Lower1
- The Express SD Stent couples excellent compression resistance with lower stent foreshortening and recoil. (acecardiopathy.com)