News | March 02, 2010

New Class of Endovascular Implant Receives CE Mark

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 to treat the highly varied presentation of atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a unique combination of strength, flexibility and vessel coverage.

CE mark approval was supported by data from NovoStent’s SAMBA trial which enrolled patients in Germany in 2009. Partial six-month results of the SAMBA trial were presented in January at the International Symposium on Endovascular Therapy by Michael Dake, M.D., of the Stanford University School of Medicine. Lesions treated in the trial included a wide spectrum of disease such as total occlusions, eccentric calcified plaque, ulcerating lesions and thrombotic occlusions. Also included in the trial were several isolated popliteal lesions. Physicians typically avoid placing stents in the popliteal artery for fear of stent fracture.

The stent features NovoStent's novel, self-expanding alternating helix technology. The SAMBA stent provides over 50 percent vessel coverage, more than twice that of slotted tube stents.

Traditional peripheral vascular stents use axial connectors that can stiffen the device and lead to fracture. Due to the absence of axial connectors and flexible design, there have been no instances of stent fracture in any of the company’s preclinical or clinical trials.

The company said the SAMBA Stent creates a new product category that combines the best attributes of stent-grafts and conventional stents. With more than 50 percent metal coverage, the SAMBA has the ability to hold back more disease than a conventional stent. But unlike a stent-graft, patency of side branch arteries can be maintained.

The company’s stents employ an ultra-thin helical macro structure with enhanced flexibility and radial strength along with a micro cell structure that can be tailored for different vascular anatomies. NovoStent's stent and integrated delivery system is designed to provide easy deployment and accurate delivery.

Approximately 12 million Americans are afflicted with PAD.

For more information: www.novostent.com

Related Content

Intact Vascular Inc. received U.S. Food and Drug Administration (FDA) market clearance for the Tack Endovascular System. This is a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).
Technology | Peripheral Artery Disease (PAD) | April 15, 2019
April 15, 2019 – Intact Vascular Inc. received U.S.
The Boston Scientific Eluvia self-expanding, drug-eluting peripheral stent. It outperformed the Cook Zilver stent in the IMPERIAL Trial presented at TCT 2018.

The Boston Scientific Eluvia self-expanding, drug-eluting peripheral stent. It outperformed the Cook Zilver stent in the IMPERIAL Trial presented at TCT 2018.

Feature | Peripheral Artery Disease (PAD) | January 30, 2019 | Dave Fornell, Editor
In recent years, there has been a lot of focus by vendors on developing better stenting technologies to treat...
The safety of paclitaxel-eluting stents and drug-coated balloons was called into question in a recent study that showed higher mortality rates after two years. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in that study.

The safety of paclitaxel-eluting stents and drug-coated balloons was called into question in a recent study that showed higher mortality rates after two years. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in that study.

Feature | Peripheral Artery Disease (PAD) | January 25, 2019 | Dave Fornell, Editor
The anti-proliferative drug paclitaxel has been used as a coating on coronary stents to prevent restenosis since 2003
Lumee Oxygen Platform Measures Treatment Response in Critical Limb Ischemia
News | Peripheral Artery Disease (PAD) | January 25, 2019
January 25, 2019 — Profusa announced promising...
BEST-CLI Trial Examining Critical Limb Ischemia Treatment Options Nears Enrollment Goal
News | Peripheral Artery Disease (PAD) | January 23, 2019
A new report in the Journal of Vascular Surgery chronicles a multi-site randomized controlled trial comparing treatment...
FDA Issues Letter About Paclitaxel Coated Balloons and Eluting Stents
News | Peripheral Artery Disease (PAD) | January 17, 2019
The U.S. Food and Drug Administration (FDA) issued a letter Jan. 17, 2019, to healthcare providers regarding a recent...
New Appropriate Use Criteria Released for Peripheral Artery Interventions
News | Peripheral Artery Disease (PAD) | December 19, 2018
A new set of appropriate use criteria (AUC) released Dec. 17 by a group of cardiovascular professional societies...
Lithotripsy Safe and Effective in Calcified Stenotic Peripheral Arteries
News | Peripheral Artery Disease (PAD) | December 04, 2018
New results from the DISRUPT PAD II study showed no perforations, embolization, reflow or abrupt closures with the...
Lutonix 014 Drug-Coated Balloon Safe and Effective Below the Knee
News | Peripheral Artery Disease (PAD) | November 07, 2018
The Lutonix Drug-Coated Balloon (DCB) showed statistically significant safety equivalence with a standard percutaneous...
Overlay Init