ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session. The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, […]
BD (NYSE: BDX) recently announced that it has begun enrollment for its post-market surveillance study of its WavelinQ arteriovenous endovascular fistula device. The Connect-AV trial is a prospective, single-arm, open-label study that will follow WavelinQ EndoAVF system patients for 24 months. Its dual primary effectiveness endpoints are the percentage of subjects dialyzing with successful 2-needle cannulation […]
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 […]
Transit Scientific today said it received CE mark clearance for its XO Score scoring sheath platform. XO Score is designed for dilation of stenotic material in the peripheral vasculature, including popliteal, infrapopliteal and native or synthetic arteriovenous dialysis fistulae. The scoring and cutting technology in the device enables low-pressure lesion dilation and vessel prep with […]
BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere. Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company. TheraSphere treatment for patients with hepatocellular carcinoma (HCC) delivers millions of glass microspheres containing radioactive […]
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 […]
Perfuze today said it received CE mark approval for its clot aspiration catheter Millipede 088. The Ireland-based company also announced that the first five acute ischemic stroke patients have been treated with the device. Get the full story on our sister site, Medical Tubing + Extrusion.
Olympus today said it has launched its product line of five H-SteriScope single-use bronchoscopes. The single-use endoscopes are for diagnostic and therapeutic procedures. They resulted from a collaboration between Olympus subsidiary Veran Medical Technologies and Hunan Vathin Medical Instrument Co. Get the full story on our sister site, Medical Tubing + Extrusion.
LeMaitre Vascular (NSDQ:LMAT) posted first-quarter results yesterday that beat the consensus on Wall Street. The company reported profits of $5.9 million, or 28¢ per share, on sales of $35.8 million, for the three months ended March 31, for a bottom-line gain of 86.8% sales growth of 17.45% compared with Q1 2020. Earnings per share were 28¢∞, […]
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, […]
Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit. Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news […]