VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor. Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology. According to a news release, a fast-track grant […]
Vascular
Abbott wins CE mark for Amplatzer steerable delivery sheath
Abbott (NYSE:ABT) announced today that it received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath. The company touts the Amplatzer sheath as the first steerable delivery sheath to be developed specifically for minimally invasive left atrial appendage (LAA) occlusion (or closure) procedures for patients diagnosed with atrial fibrillation who are at […]
Philips touts 2-year data for Tack endovascular system
Royal Philips (NYSE:PHG) today announced positive two-year results from a clinical trial of the Tack endovascular system. Amsterdam-based Philips presented data from the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial at the 2021 New Cardiovascular Horizons Conference, according to a news release. Data presented by co-principal investigator Dr. George Adams, an interventional […]
Boston Scientific stent recall is Class I
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 […]
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 […]
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¢ […]
Penumbra slides on Street-beating Q1 results
Penumbra (NYSE:PEN) yesterday posted first-quarter results that beat the earnings consensus on Wall Street and matched sales estimates. The Alameda, Calif.-based company reported profits of $11.836 million, or 32¢ per share, on sales of $169.2 for the three months ended March 31, for a bottom-line gain of 730.6% sales growth of 23.2% compared with Q1 […]
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 […]
Vascular Therapies touts surgical stenosis treatment trial despite missed primary endpoint
Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes. Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to a […]
4 catheter-based devices to watch for in 2021
Medical device companies are working to gain regulatory approvals and launch new catheter-based devices as the world slowly returns to normal after reeling from the COVID-19 pandemic. As of April 19, the FDA had approved 11 medical devices this year — two of them catheter-based. In comparison, the regulatory agency approved 19 devices by April 19 last year. However, […]
This device stops aorta blood flow to save lives
Stopping internal bleeding from torso trauma has its technological challenges. Asha Parekh, co-founder and CEO of Front Line Medical Technologies, has developed a small, quick and easy device that could solve the problem. Front Line Medical Technologies (London, Ontario) is an early-stage medical device company that is developing a way to stop internal bleeding with […]
