The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall. Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA […]
Stents
5 of the latest cardiac tech insights out of ACC.21
The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech. Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology […]
DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing
In this week’s episode of the DeviceTalks Weekly Podcast, Boston Scientific peripheral business EVP Jeff Mirviss explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” in the body. Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business. […]
Boston Scientific initiates coronary drug-coated balloon study in U.S.
Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]
InspireMD dips despite Street-beating Q1
InspireMD (NYSE:NSPR) shares slid today despite first-quarter results that topped the consensus forecast. The Tel Aviv, Israel-based company posted losses of -$3.2 million, or -53¢ per share, on sales of $1 million for the three months ended March 31, 2021, for a -64% bottom-line slide on a sales decline of -2.7%. InspireMD’s EPS of -53¢ […]
Micro Medical Solutions wins FDA breakthrough device designation for vascular stent
Micro Medical Solutions today said it has received FDA breakthrough device designation for its MicroStent vascular stent. The stent is designed to maintain vessel patency, enhance wound treatment and improve quality of life and blood flow to reduce amputations and mortality for patients with critical limb-threatening ischemia (CLTI) from peripheral artery disease. “FDA breakthrough device […]
Boston Scientific, Stryker may get extension on Medicare payments
CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker. Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute […]
Abbott launches AI-powered coronary imaging platform in Europe
Abbott (NYSE:ABT) announced today that it launched its new coronary imaging platform in Europe as it is now CE marked. The platform, powered by Ultreon 1.0 software, merges optical coherence tomography (OCT) with AI to enhance visualization and detect the severity of calcium-based blockages and measure vessel diameter, according to a news release. The goal […]
FDA says Cordis carotid artery stent recall is serious
The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall. Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. The […]
Contego Medical carotid stent wins CE mark approval
Contego Medical recently announced that it received CE mark approval for its Neuroguard IEP 3-in-1 carotid stent system and post-dilation balloon system with integrated embolic protection. The system has a nitinol stent, a pre-positioned post-dilation balloon and a microembolic filter with 40 μm pores. It has a closed-cell stent that is designed for optimal performance […]
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
