In November 2011, we reported the preliminary results of the REMEDEE clinical trial for the Combo Dual Therapy stent from OrbusNeich (Hoevelaken, Netherlands). The stent was developed to promote endovascular healing and cut the risk of restenosis compared to current bare-metal and drug-eluting stents. The randomized REMEDEE trial (Randomized Evaluation of an abluMinal sirolimus coatED bio- Engineered stEnt) found that the Combo Dual Therapy stent was non-inferior to the TAXUS Liberté paclitaxel-eluting stent based on in-stent late lumen loss at nine months.

More recently, at EuroPCR 2012, the company has announced the 12-month follow-up from the study. Data from that study indicate that the stent was associated with favorable clinical and safety outcomes over the TAXUS Liberté stent.

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Medtronic has received expanded clearance for a bunch of new indications for its flagship Resolute Integrity drug eluting coronary stent in countries using the CE Mark. It was previously labeled for use in patients with diabetes and multi-vessel disease, but is now also approved for acute coronary syndromes, acute myocardial infarction, unstable angina, bifurcations, in-stent restenosis, total occlusions and chronic total occlusions.

Recent clinical study results, according to the latest company’s announcement:

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It seems that renal denervation systems are popping up like daisies these days. Today at the EuroPCR meeting in Paris, France, St. Jude Medical announced CE Mark Approval and the launch of its EnligHTN renal denervation system. Like other renal ablative systems, this one is approved to reduce blood pressure in patients with hypertension resistant to medical therapy.

Similar to the Vessix Vascular V2 system, the EnligHTN has multiple electrodes which potentially saves time during the ablation procedure, as four ablations can be performed without catheter repositioning.

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The FDA has approved the Lumax 740 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D) from BIOTRONIK.

The Lumax 740 line, which was designed to help physicians monitor and treat arrhythmias and heart failure, features the company’s proprietary SMART Detection technology to reduce the incidence of inappropriate shocks to the heart.

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Hitachi Medical Systems received FDA clearance for its Echelon Oval 1.5T Ultra-Wide MR system. The Echelon Oval has a bore that is, as the name implies, oval-shaped, very much unlike conventional MRI systems which have a round bore. The opening is 65cm high and 74cm wide, accommodating even the largest patients and reducing feelings of claustrophobia. When the spine coil is used, this results in approximately 40% more examination space compared to conventional MRI systems.

Looking further than just the shape and size of the bore, the Echelon Oval’s imaging capabilities include non-contrast MRA, isotropic image acquisition and robust fat suppression. It features Hitachi’s Workflow Integrated Technology (WIT) suite which includes an integrated coil system and a wide mobile table.

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Medtronic is introducing its Valiant Captivia Thoracic Stent Graft in the U.S, China and Japan after receiving all the relevant regulatory clearances in those markets. The device, which received European approval back in October 2009, is indicated in the U.S. for “endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a non-aneurysmal aortic diameter in the range of 18–42 mm and non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm.”

The Valiant Captivia features eight peaks and troughs on each metal support ring, and by getting rid of the longitudinal connecting bar, such as on the company’s older Talent Thoracic Stent, the device is made more flexible and easier to apply inside tortuous aortas.

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Covidien is the latest in a line of companies entering the renal denervation business, as it will unveil its new OneShot renal denervation system at the EuroPCR (European Association for Percutaneous Cardiovascular Interventions) congress in Paris, France, on May 16. Like all other recently introduced denervation systems, it is intended to treat patients with hypertension who are not responsive to traditional medical therapy.

The OneShot system is an irrigated, radiofrequency (RF) based balloon catheter used to ablate the renal sympathetic nerves located in the outer wall of the renal arteries. The OneShot technology received CE mark clearance in February 2012. If you are attending EuroPCR, it will be possible to watch two denervation procedures that will be transmitted live from Leipzig, Germany.

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Navilyst Medical out of Marlborough, MA, which is expected to become part of AngioDynamics by the end of May, has launched in the U.S. its Embarc Microcatheter with Glyce hydrophilic coating, a catheter made for diagnostic and interventional use in peripheral vessels.

The device has a kink resistant shaft, a special coating for smooth delivery, and a number of other features to make it easier to operate in difficult anatomy.

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Just two days after we reported on the design story behind the Vessix V2 renal denervation system,Vessix Vascular is now announcing it has received European CE Mark approval for its percutaneous radiofrequency balloon catheter technology for the treatment of hypertension. According to the company, the system is faster, easier to use and less painful for patients than any renal denervation system currently available on the market.

The V2 is approved for use in patients with uncontrolled hypertension despite taking three or more anti-hypertensive medications. In these patients, renal denervation may reduce systolic blood pressure by approximately 20 percent, thereby greatly reducing the risk of stroke and cardiovascular disease.

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Cameron Health (San Clemente, CA), which was purchased in March by Boston Scientific, is reporting that the FDA’s Circulatory System Devices Panel has recommended approval for its S-ICD system, an implantable defibrillator that unlike traditional ones does not use intracardiac leads. Instead, an electrode implanted vertically under the skin on the chest senses the heart’s electrical signals and corrects them with appropriate shocks.

Though the recommendation for approval points to a likely final clearance of the device by the US FDA, the latest study of the S-ICD system did show it generates more unnecessary shocks, leads to more infections, and loses battery life faster than traditional ICDs.  According to Bloomberg wire’s Apr 23, 2012 article, “Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.”

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