Stents

Covidien’s past acquisitions keep coming up trumps. EV3’s Everflex™ device has now been cleared for US marketing by FDA, bringing a useful new long stent option to peripheral vascular surgeons.

Abbott’s Absolute Pro Stent for Iliac Disease has gained FDA clearance. The product is designed for precise stent placement and Optimal Flexibility to Conform to Challenging Lesions.

How to stent a sidebranch. Cappella knows how and has now supplemented CE mark for its Sideguard® system with Indian approval.

A new publication casts doubt on stenting of stable coronary artery disease patients as a supportable first treatment.

Cook’s Zilver PTX Becomes First SFA Stent and first Drug-Eluting Peripheral Stent

We’re a truly schizophrenic lot aren’t we? We embrace technology like this, then moan that we have lax regulatory control. Regardless of the argument, the fact is that this tiny Japanese company’s PLLA stent is approved in EU, but not USA or Japan.

Solid figures, but it’s not quite all good news at Medtronic as sales in some divisions suffer, especially in USA.

Medtronic Inc’s Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes.

In short Stryker’s brain stent has been used in USA since 2005 on a Humanitarian Device Exemption (HDE) basis and … continue reading “Stryker’s Wingspan: A Regulatory Conundrum For FDA?”

Boston Scientific is sounding pretty pleased with itself as it publicises positive results from three major studies on its WallFlex® enteral stent family of products.

Patients who underwent coronary angioplasty with InspireMD’s MGuard coronary stent exhibited statistically significant improvement in microvascular reperfusion criteria compared with those treated with traditional bare metal stents (BMS).

Abbott is sounding very pleased with itself about its drug-eluting stent sales figures, which it claims confirms its status as global market leader.

Covidien’s Everflex system, designed to treat long vascular lesions with a single stent, is the subject of an extensive clinical study, interim results of which have been released. The stent is already approved for use in Europe.

Abbott Laboratories has announced that it will lay off 700 employees as part of ongoing restructuring efforts, 300 of the redundancies coming from the company’s Stent Division in Southern California.

You say sirolimus, I say everolimus… judge says lets call the whole thing off.

Cook Medical, is to invest up to €16.5m over four years creating highly skilled positions in Research and Development activities at its Limerick site, with Government support through IDA Ireland.