Boston Scientific today said it received CE mark approval for its Exalt Model B single-use bronchoscope. The Marlborough, Mass.–based company designed the device for bedside procedures in the intensive care unit, operating room and bronchoscopy suite. Exalt Model B is available in three sizes — slim, regular and large — for procedures such as … [Read more...] about Boston Scientific gets CE mark approval for single-use bronchoscope
FDA clears EndoFresh disposable digestive endoscope
EndoFresh today said it received FDA 510(k) clearance for its disposable digestive endoscopy system. The system features a camera system with an all-in-one design, disposable upper GI endoscope and disposable colonoscope, which can be used with the company's medical display and other peripheral devices for physicians to visualize, diagnose and … [Read more...] about FDA clears EndoFresh disposable digestive endoscope
Is renal denervation back as a high blood pressure treatment?
Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system. The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its … [Read more...] about Is renal denervation back as a high blood pressure treatment?
ReCor Medical has positive renal denervation study news
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 … [Read more...] about ReCor Medical has positive renal denervation study news
Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients
Edwards Lifesciences‘s Evoque tricuspid valve replacement system reduces tricuspid heart valve leakage to non-traceable or mild leakage in 98% of patients, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session. Evoque is designed to replace native tricuspid valves without open-heart surgery. The … [Read more...] about Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients
Galaxy Medical, Japan Lifeline ink distribution agreement for ablation catheters
Galaxy Medical and Japan Lifeline today said they signed an exclusive distribution agreement for the Alpha1 ablation catheter. Under the agreement Galaxy will pursue U.S. regulatory approval for Japan Lifeline's Alpha1 in support of the commercialization of Galaxy's Centauri pulsed electric field system, which can be used with the ablation … [Read more...] about Galaxy Medical, Japan Lifeline ink distribution agreement for ablation catheters
BD enrolls first patients in arteriovenous endovascular fistula post-market trial
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 … [Read more...] about BD enrolls first patients in arteriovenous endovascular fistula post-market trial
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 … [Read more...] about Boston Scientific initiates coronary drug-coated balloon study in U.S.
Endologix launches Alto abdominal stent graft in Canada
Endologix (NSDQ:ELGX) today said it launched its Alto abdominal stent graft in Canada following its recent Health Canada approval. The Alto abdominal stent graft system is a polymer-based therapy for abdominal aortic aneurysm (AAA) patients. It uses a low-profile delivery system with a conformable sealing ring that molds in-situ to the patient's … [Read more...] about Endologix launches Alto abdominal stent graft in Canada
NXgenPort, Mayo Clinic ink license agreement over chemo-port catheter for home monitoring
NXgenPort today announced that it has entered into a license agreement with Mayo Clinic to develop and test an implantable chemo-port catheter. NXgenPort's technology has chemo-port efficacy with sensor technology to measure and remotely monitor the early onset of complications by reporting and tracking patient response during … [Read more...] about NXgenPort, Mayo Clinic ink license agreement over chemo-port catheter for home monitoring
