Category — Medical Devices

According to a recent article in Forbes this may well be the case. The argument is that as a result of highly differentiated healthcare delivery not perhaps providing the value added clinical and economic benefits - patients may have to turn to a more generic (and effective?) form of healthcare delivery.

While this story is mainly about pharmaceuticals it may well apply to homecare products as is evidenced by NCART - National Coalition For Assistive And Rehab Technology and others actively campaigning to have complex rehab products excluded from the National Competitive Bidding program.

American Journal of Cardiology - Clinical and Angiographic Outcomes After Placement of Multiple Overlapping Drug-Eluting Stents in Diffuse Coronary Lesions In this recently published clinical trial by Cheol Whan Lee, [Read more →]

Abbott Begins Early International Launch of XIENCE™ Everolimus Eluting Coronary Stent System

“XIENCE V showed statistically significant superiority to the TAXUS® paclitaxel-eluting coronary stent system”.
Related post here

The FDA issued a statement September 14, 2006 following the controversy from papers presented at the presented at the March 2006 American College of Cardiology Scientific Sessions in Atlanta GA - (Basket-Late study) and more recently the Sept 2006 European Society of Cardiology Annual Meeting/World Congress of Cardiology Meeting in Barcelona Spain - (the Camenzind meta-analysis).

FDA Statement on Coronary Drug-Eluting Stents

At this time, FDA believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year.

This was the conclusion of the statement however the FDA is working closely with the two manufacturers - read Boston Scientific and Johnson and Johnson to monitor long term clinical studies and will soon hold a public panel on the subject.

See related posts:

Do Drug Eluding Stents DES increase Deaths

NEJM — Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction

The stent debate continues.
NEJM — Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction
Background Sirolimus-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of such stents in primary percutaneous coronary intervention (PCI) for acute myocardial infarction with ST-segment elevation.

This The Red Hot Market for Medical Devices in China - SeekingAlpha is an excellent article from Evelyn Rubin which reviews the IPO filing by Mindray - a medical device manufacturer with a substantial China presence.

The filing contains a host of useful information on the Chinese medical products market.

Gray Surgical is a West Australian based company and is 100% Australian owned. We have been in operation since 1996 as a designer and manufacturer of premium quality surgical retractors. Surgical retractors are instruments that are used during extended surgical operations in order to provide maximum exposure for the surgeon.

GRAY SURGICAL is committed to providing surgeons and hospitals with excellence in products and service.

Our range of table mounted surgical Retractors and Instrument Holders are designed to provide optimal surgical exposure and are compatible with most other retraction systems.

In addition, our products are ISO 9001/2000 accredited, FDA approved, TGA approved and have CE certification for distribution throughout Europe.

We are actively seeking to expand our distribution network in the USA, South Africa, Canada, Israel, Greece, South America, Saudi Arabia, Austria, Russia, Singapore/Malaysia (South East Asia), Turkey, Eastern European countries and would welcome enquiries from suitably qualified parties. Email us at gray@graysurgical.com