Tag: critical limb ischaemia

Tack Endovascular System launches in the EU with first commercial use...

The first commercial use of the Tack Endovascular System (Intact Vascular) has taken place in multiple hospitals within Germany. A novel therapy for dissection...

First European patients treated with Peripheral Orbital atherectomy system

The first patients in Germany have been treated with the Stealth 360 Peripheral Orbital Atherectomy System (OAS; Cardiovascular Systems Inc). The German cases represent...

Lutonix 014 DCB gathers first randomised evidence of positive safety and...

Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...

First US implants of MicroStent for peripheral arterial disease take place

MicroStent (Micro Medical Solutions), a vascular stent designed to reduce below-the-knee amputations caused by critical limb ischaemia (CLI) resulting from peripheral arterial disease (PAD)...

Intraoperative oxygen monitoring predicts wound healing in critical limb ischaemia patients...

Preliminary findings from an initial study with 25 patients have shown that measuring the changes in oxygen concentration at baseline, during, and after endovascular...

BD announces completion of enrolment in Lutonix 014 DCB below-the-knee trial

Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration...

Hyperspectral imaging for assessing regional foot perfusion

There has been significant progress in limb salvage in patients with peripheral artery disease (PAD) and critical limb ischaemia (CLI) over the past two...

Positive results from pilot study of LimFlow Percutaneous Deep Vein Arterialization...

LimFlow announced on 1 August 2017 publication of positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in...

The search for modifiable risk factors to improve bypass results is...

A large study of the outcomes of 3,033 patients undergoing lower extremity bypass has reported a 10.6% infection rate and identified procedural risk factors....

Eyes may hold clues to future narrowing of leg vessels

Changes in tiny blood vessels of the eye may predict a higher risk of later narrowing in the large blood vessels in the legs,...

Medtronic launches European below-the-knee clinical study of drug-coated balloon

Medtronic has launched the IN.PACT BTK study to evaluate the effectiveness of using a drug-coated balloon in patients with below-the-knee (BTK) peripheral artery disease. This...

Micro Medical Solutions receives CE mark for MicroStent

Micro Medical Solutions (MMS) has received CE mark approval for MicroStent, allowing the company to market this technology in Europe. MicroStent is a vascular...

TOBA II BTK clinical trial commences enrolment with first implant of...

Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and...

BEST-CLI trial enrolment nears halfway mark

As the second year of enrolment draws to a close, the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI)...

Tack endovascular system secures CE mark for repair of dissections following...

Intact Vascular has attained the CE mark for the Tack endovascular system for the repair of arterial dissections following percutaneous transluminal angioplasty (PTA) below...

Intact Vascular closes on additional funding to advance development of Tack...

Current Intact Vascular investors—New Enterprise Associates, Quaker Partners and HIG BioHealth Partners—have exercised their right to invest additional capital as part of the company’s...

Spectranetics receives CE mark for Stellarex 0.014 drug-coated balloon

Spectranetics’ Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease, and challenging...

FDA approves TOBA II BTK pivotal IDE clinical study

The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular’s investigational device exemption (IDE) application to begin its TOBA II BTK...