MASSDEVICE ON CALL —St. Jude Medical (NYSE:STJ) landed CE Mark approval and announced commercial launch for its Enlightn renal denervation system as a treatment for hypertension.
The Enlightn system is one of the 1st to use multiple electrodes to ablate the nerves that contribute to high blood pressure, possibly improving consistency and procedural reliability, according to a press release.
The Enlightn system will compete against some big players, including Medtronic’s (NYSE:MDT) Symplicity system, gained through the January 2011 acquisition of Ardian, which is on the road to FDA review with clinical trials approved in the U.S. last summer. The device has CE Mark approval and TGA listing in Australia and last month won clearance from Health Canada.
Fellow med-tech giant Covidien (NYSE:COV) recently vaulted into the renal denervation space with a surprise introduction of its OneShot system, which also has CE Mark approval in the European Union. The OneShot system was gained through the acquisition of Maya Medical late last month in a deal worth up to $230 million.
The renal denervation space is a hot one, and not without reason. Cleveland Clinic named catheter-based renal denervation to control resistant hypertension the No. 1 innovation for 2012, with the potential to spread to treating chronic kidney disease, insulin resistance and heart failure.
St. Jude also released data from its Fame II trial, demonstrating the value of fractional flow reserve-guided assessment in determining which patients are best treated with optimal medical therapy rather than percutaneous coronary intervention, potentially lowering the need for unplanned hospital readmission and urgent revascularization in patients with stable coronary artery disease. Read more
Biotronik unveils positive outcomes from the 12-month follow-up of patients implanted with the Pro-Kinetic Energy bare metal stent system in more than 1,000 patients in patients with acute coronary syndrome or small vessels, as well as in patients with diabetes and the elderly. Read more
Volcano (NSDQ:VOLC) plans to highlight its FFR and Instant Wave-Free Ration Functionality product portfolio, showcasing new measurement technologies, including the company’s latest Primewire Prestige Plus pressure guidewire. Read more
Abbott (NYSE:ABT) wins expanded CE Mark indication for its Xience Prime and Xience V everolimus-eluting coronary stents, now approved for a minimum of 3 months of dual anti-platelet therapy, the shortest duration for any drug-eluting stent in Europe. Read more
Svelte Medical closes patient enrollment in its Direct drug-eluting stent study, a 1st-in-man study designed to evaluate its All-In-One stent system. Read more
Stentys launches its Stentys AC aspiration catheter, designed to safely remove clot chunks from the coronary arteries prior to implanting a stent. Read more
Neovasc (NYSE:NVC) touts clinical studies for its Tiara transcatheter mitral valve disease therapies, showing successful implantation in animal models. Read more
Infraredx introduces its TVC device, an intravascular imaging system for assessing vessel composition and structure by using integrated near-infrared spectroscopy, enhanced intravascular ultrasound and imaging technology. Read more
Capella Medical Devices releases 6 month follow-up data for its Sideguard coronary sidebranch system, designed to treat bifurcation disease. Read more
