News

FDA Abbott Supera Self-Expanding Stent Peripheral Artery Disease

The U.S. Food and Drug Administration (FDA) approved Abbott’s Supera Peripheral Stent System to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD...

Espirt Bioresorbable Vascular Scaffold BVS Peripheral Artery Disease PAD

Six-month results of the ESPRIT trial suggest a bioresorbable drug-eluting scaffold is effective in opening...

balloon catheters peripheral artery disease intact vascular tack-it

Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, announced the start of enrollment in the Tack Optimized ...

stents peripheral clinical triady study S.M.A.R.T. nitinol stent cordis

Researchers at Saint Luke’s Mid America Heart Institute led a study that showed marked, long-term improvement...

October 23, 2013 — Vascular Interventional Advances (VIVA) Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and...

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Bard Peripheral Vascular has sent an urgent Class I medical device recall notification letter informing customers of the problems of the LifeStent Solo ...

stents peripheral atherectomy devices artery disease PAD covidien everflex

Covidien released positive final results from its Durability II study and promising preliminary data from its Definitive AR trial at the Vascular Interventional Advances (VIVA) 2013 conference in...

boston scientific stents peripheral clinical trial study innova des drug-eluting

Launching a clinical trial expected to serve as the foundation for global regulatory approvals, a physician in...

stents peripheral peripheral artery disease pad clinical trial study bioflex

Biotronik announced it has completed patient enrollment in the iliac arm of its Bioflex-I trial. Under the supervision of Mark Burket, M.D. and chief, Cardiovascular Division at the University of...

stent peripheral artery disease treatment complete se medtronic

Expanding its role in the treatment of peripheral artery disease in the United States, Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Complete...

August 28, 2013 — Effective Oct. 1, Cook Medical’s Zilver PTX drug-eluting peripheral stent qualifies for new-technology add-on payments under Medicare’s hospital inpatient prospective...

Millenium Research Group, Stents (peripheral), Cath Lab,

According to Millennium Research Group (MRG), efforts to streamline the regulatory approval process in Japan have resulted in the recent entry of numerous devices in the Japanese...

Boston Scientific Corp. has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter clinical trial evaluating the long-term (12-month) safety and...

Cook Medical is again shipping its Zilver PTX drug-eluting peripheral stent to medical centers in the United States, Japan, Europe and other major markets. The shipments follow a brief period...

Abbott Technologies Acquires IDEV Technologies

Abbott announced that it has entered into an agreement to purchase IDEV Technologies, a privately held company focused on developing next-generation medical devices for use by interventional...

Cordis Corp. announced it has completed the acquisition of Flexible Stenting Solutions Inc., whose technology provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to...

Biotronik BIOFLEX-I IDE Clinical Trial Puslar-18 Peripheral Artery Disease

Biotronik announced the first U.S. implant of their Pulsar-18 self expanding stent in the BIOFLEX-I IDE clinical trial. Carlos Mena of Yale University Medical Center performed the procedure.

December 26, 2012 — Flexible Stenting Solutions Inc. (FSS) announced it gained CE mark in the European Union for its 6 French Reconstrainable FlexStent Femoropopliteal self-expanding...

More than half of patients treated for claudication or critical limb ischemia (CLI) with stenting of the superficial femoral artery (SFA) had primary patency at five years, says a recent study.

PAD Treatment Devices Stent Peripheral Cordis Corp. S.M.A.R.T., SMART, SFA stent

Cordis Corp. announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. Control Vascular Stent Systems for use in the superficial femoral artery (SFA) and/or the...

Cook, Zilver PTX, stent, expanding, delivery sheath

The U.S. Food and Drug Administration (FDA) granted market clearance for Cook Medical’s Zilver PTX drug-eluting peripheral stent. It is the first device of its kind on several fronts to go...

October 23, 2012 — In the DEBATE-SFA trial, researchers found that the use of a paclitaxel drug-eluting balloon (DEB) to widen the artery prior to implanting a self-expanding nitinol stent yielded...

Zilver PTX Randomized Controlled Trial Stents Peripheral artery disease (PAD)

Three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease from Cook Medical demonstrate 70.7 percent primary patency in the...

Cook Medical Zilver Vena Venous Self-Expanding Stent

Following Health Canada approval, Cook Medical has made the Zilver Vena Venous Self-Expanding Stent available to physicians across Canada. Designed to restore blood flow in obstructed iliofemoral...

Boston Scientific Promus Element Plus BTK Stent

Boston Scientific has launched the Promus Element Plus BTK (Below The Knee) everolimus-eluting stent system in European countries for the treatment of certain severe peripheral artery lesions. The...

August 22, 2012 — Authors of an article in the Journal of Endovascular Therapy have evaluated the effectiveness of endovascular brachytherapy using liquid beta-emitting rhenium-...

August 15, 2012 — Previously unreleased three-year data from the Zilver PTX randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease indicate that Cook Medical’s...

Aug. 8, 2012 — The U.S. Food and Drug Administration (FDA) approved the Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. This...

July 12, 2012 — Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, announced the completion of U.S. patient enrollment...

July 3, 2012 — Flexible Stenting Solutions Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced that it has extended its CE...

May 23, 2012 -- Boston Scientific Corp. announces U.S. Food and Drug Administration approval and market launch of the Epic Vascular Self-Expanding Stent System. The Epic Stent is designed to open...

May 17, 2012 — Boston Scientific Corp. announces CE mark and European market launch of the Innova Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular...

March 16, 2012 — The U.S. Food and Drug Administration (FDA) approved the premarket approval (PMA) application for the Covidien EverFlex self-expanding peripheral stent system.

March 6, 2012 — In a development that brings advanced combination therapy treatment of peripheral artery disease (PAD) to Japanese patients for the first time, Cook Medical has received PMDA...

January 18, 2012 — Boston Scientific reported nine-month clinical endpoint data from its ORION trial, demonstrating positive outcomes for the Epic self-expanding nitinol stent in patients with...

Abbott announced the initiation of ESPRIT I, a first-of-its-kind clinical trial in Europe evaluating the safety and performance of the novel Esprit drug-eluting bioresorbable vascular scaffold (...

November 4, 2011 — Medtronic Inc. announced approval by the U.S. Food and Drug Administration (FDA) of the Assurant Cobalt Iliac Balloon-Expandable Stent System.

November 1, 2011 – Boston Scientific released the schedule of its major events and product-related clinical research for the Cardiovascular Research Foundation's (CRF) 23rd annual Transcatheter...

A U.S. Food and Drug Administration (FDA) review panel has given its unanimous recommendation for the market approval of the Zilver PTX stent. It is the first device of its kind on several fronts...

October 5, 2009 – In a breakthrough development that could dramatically reduce the number of leg amputations and painful bypass graft surgeries performed annually on European patients, a first-of-...

January 20, 2011 – Drug-coated stents hold promise as a safe and lasting solution for the treatment of clogged leg arteries, suggest two-year results of the Zilver PTX Trial being presented at the...

October 3, 2011 Maquet Cardiovascular has signed a definitive agreement to acquire Atrium Medical Corp. for $680 million. Atrium is a medical device technologies developer for...

September 13, 2011 – An U.S. Food and Drug Administration’s (FDA) will discuss recommendations for Cook Medical Zilver PTX self-expanding drug-eluting peripheral stent at its Oct. 13, 2011,...

August 10, 2011 – The U.S. Food and Drug Administration (FDA) has approved Abbott’s RX Herculink Elite Renal Stent System for the treatment of renal artery stenosis (narrowing of the main arteries...

August 2, 2011 – The U.S. Food and Drug Administration recently cleared Abbott Vascular’s RX Herculink Elite Renal Stent System. The balloon-expandable, cobalt chromium, laser-cut stent is used to...

July 20, 2011 — IDEV Technologies Inc. announced the completion of enrollment in the SUPERB trial, a U.S. Food and Drug Administration (FDA)-approved IDE trial evaluating the use of IDEV's Supera...

July 18, 2011 — NSVascular Inc., a newly formed subsidiary of NeuroSigma Inc., has signed an exclusive license with the University of California Los Angeles (UCLA) covering its medical...

June 17, 2011 — The U.S. Food and Drug Administration (FDA) said Boston Scientific has issued a class I recall for its Innova Over-the-Wire Self-Expanding Stent System, because of complaints of no or...
June 3, 2011 - IDEV Technologies announced that data from a long lesion study of 182 patients with significantly diseased superficial femoral arteries and popliteal arteries showed high patency rates...
May 10, 2011 – Patients suffering from blockages of the arteries to the kidneys now have access to a new stenting treatment option with the launch of Cook Medical’s Formula Renal Balloon-Expandable...

April 13, 2011 – Patient enrollment has begun for the SuperNOVA clinical trial. It will examine the safety and effectiveness of Boston Scientific’s Innova self-expanding bare-metal stent in...

January 27, 2010 – The U.S. Food and Drug Administration (FDA) expanded the indication for the Bard Peripheral Vascular LifeStent and LifeStent XL nitinol self-expanding stents for the treatment...

January 24, 2011 – A new device for treating peripheral artery disease (PAD) is now available in Europe. W.L. Gore and Associates announced the availability of its Viabahn Endoprosthesis on a...

January 20, 2011 – European CE mark approval was granted to expand the indication of Abbott’s Xience Prime everolimus-eluting coronary stent for the treatment of critical limb ischemia (CLI) or...

January 13, 2011 – Enrollment has finished for the ORION trial designed to test the Epic self-expanding nitinol stent to treat iliac artery disease.

The trial will examine rates of device-...

November 24, 2010 – Results for a trial comparing a drug-eluting stent to balloon angioplasty and bare metal stenting in treating restenosis after angioplasty were announced at the VEITHsymposium...

November 5, 2010 – The final patient has been enrolled in a trial studying a balloon-expandable covered stent for those with occlusive disease of the iliac artery. The iCARUS trial is...

October 1, 2010 – The Bradenton Cardiology Center is the first clinic in the United States to implant a peripheral self-expanding stent as part of the OSPREY study. The trial, which is evaluating...

September 27, 2010 – A post-market study investigating a new treatment for peripheral artery disease of the superficial femoral artery (SFA) has completed enrollment.

The VIPER study, which...

September 27, 2010 – A premarket approval (PMA) application has been submitted for the Formula balloon-expandable stent to help treat patients suffering from renal artery stenosis. Cook Medical’s...

August 19, 2010 – The Cardiovascular Research Foundation recently announced the late-breaking trials and first report investigations being presented at the Transcatheter Cardiovascular...

August 9, 2010 – Enrollment was recently completed in a clinical trial of Medtronic’s Complete SE (self-expanding) vascular stent for the treatment of atherosclerosis in the superficial femoral...

July 26, 2010 – Today a fourth-generation intracranial aneurysm stent
system was released in both the U.S. and European markets. Boston Scientific’s Neuroform EZ Stent System is designed for...

June 14, 2010 – A self-expanding, polymer-free, drug-eluting peripheral stent has been submitted for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA). Cook Medical submitted...

May 27, 2010 – One-year data presented this week at EuroPCR in Paris confirms sustained clinical outcomes with Cook Medical's drug-eluting peripheral stent, Zilver PTX.

May 21, 2010 – A new stent delivery system is designed to be reliable, easy to use and precise when delivering the self-expanding Supera peripheral vascular stent. The new delivery system was...

May 12, 2010 – The U.S. Food and Drug Administration (FDA) cleared the way for a clinical trial to evaluate the safety and effectiveness of the Misago self-expanding stent for use in the...

May 10, 2010 – Patients treated with the Zilver PTX drug-eluting peripheral stent maintained clinical improvement at two years, according to interim results from the Zilver PTX Global Registry....

April 22, 2010 – Broadening its product scope into the peripheral artery disease market, Medtronic today received U.S. Food and Drug Administration (FDA) clearance for the Complete SE Vascular...

April 21, 2010 – More than 100,000 amputations are performed each year in the United States on patients with critical limb ischemia (CLI), the most severe form of peripheral arterial disease (PAD...

March 11, 2010 – The FDA has cleared the first low-profile, premounted, balloon-expandable stent system for use in treating iliac artery disease.

The Express LD Iliac Stent is designed to...

March 2, 2010 — A new stent and delivery system for the treatment of peripheral artery disease (PAD) received CE mark approval this week.

The SAMBA Stent and delivery system was designed...

January 27, 2010 – New 6, 7 and 8 mm diameters of the Maris Plus self-expanding peripheral stent system, were launched today in Europe for interventions involving the superficial femoral arteries...

November 10, 2009 – The latest data from seven studies focused on the treatment of peripheral arterial disease (PAD) were presented in the late-breaking trials session of the Vascular...

October 27, 2009 – Interim six-month clinical results on the use of the FlexStent Femoropopliteal Self Expanding Stent System in the Superficial Femoral Artery were presented today at the VIVA...