Stents

The theory is based on sound principles. Insert a coronary stent that is able to expand to adapt to changing vessel size and it will be more effective as the vessel dilates and clot dissolves. Now FDA’s approval of an IDE study will allow Stentys to back its claims.

Five-year results from the LEADERS trial, showed improved long-term clinical outcomes for BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, compared to J&J’s Cypher® Select™, sirolimus-eluter coated with a durable polymer.

In theory combining wire, balloon and coronary stent into a single delivery system will make life easier and quicker for physicians. The U.S.FDA has now sanctioned an investigational study into Svelte’s new IDS which the company claims ticks those particular boxes.

Lombard Medical Technologies PLC, is confident it will jump the final hurdles as it gains written feedback from the U.S. FDA on the PMA application for Aorfix™, the Company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms.

Clinical study results presented this week are being touted as support for the theory that by inducing a three dimensional component into a mechanical stent, its flow characteristics will mimic the natural geometry of human vessels.

Cook Medical made the Zilver Vena™ Venous Self-Expanding Stent available to physicians across Canada at last week’s 2012 Annual Meeting of the Canadian Society for Vascular Surgery. Designed to restore blood flow in obstructed iliofemoral veins, Cook says the purpose-designed stent provides physicians with a tool designed specifically for the task.

InspireMD, Inc. has announced that Ofir Paz, co-founder, board member and Chief Executive Officer of InspireMD since its founding in 2005, intends to step down as CEO as part of a planned transition to prepare the Company for formal commercialisation of its proprietary MGuard™ Embolic Protection Stent (EPS) platform technology for patients with Acute Myocardial Infarction.

Stentys is a French-headquartered medical technology company commercialising the world’s first and only self-apposing stent to treat Acute Myocardial Infarction (AMI). The company has announced the European commercial release of an enhanced stent-delivery system for its Self-Apposing® stent. The change involves use of a new catheter to implant the stent, which has a hydrophilic coating and an ergonomic handle that considerably facilitates stent implantation in tortuous vessels.

Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.

Abbott says the potential long-term benefits of a scaffold that dissolves are significant and include a return of vessel function. CE mark and approval in many other countries sees availability widen for this first-in-class solution.

Biotronik has introduced its Pulsar stent technology in a 0.035″/6F platform, building on what it claims is the success of its Pulsar 18, 0.018″/4F version. It’s also trumpeting a new infrapopliteal PTA balloon called Passeo 14 which it claims offers a new level of utility with the promise of shortened procedure time.

It seems renal artery disease is a bigger predictor of one’s demise than coronary artery disease, so it’s perhaps reasurring to see a paper claiming that stenting of the renal arteries is an effective measure in reducing blood pressure over a sustained period.

German Neurovascular device company Acandis, has announced the CE mark approval of its novel Acclino® 1.9F low profile stent system, designed for use in the interventional neurovascular field as an adjunctive product in treating intracranial aneurysms with coils.

Elixir Medical claims to be the first company to now offer both durable and biodegradable polymer platforms for DES with the news that its absorbable polymer/drug eluting technology has been CE marked in the form of its DESyne BD Novolimus eluting stent system.

Compared with a bare-metal stent, the use of a stent with a biodegradable polymer that releases the drug biolimus resulted in a lower rate of major adverse cardiac events at 1 year among patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention according to a study in the August 22/29 issue of the Journal of the American Medical Association (JAMA).

Before we saw the numbers we were backing the line that it would be stents up, pacing and spine down, and so it came to pass. Medtronic’s numbers show the importance of emerging markets and contributions from its newly acquired businesses as the company posts 5% revenue gains.