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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Sepsis is a huge problem, costing billions of dollars and hundreds of thousands of lives a year in the US alone. A Toronto, Canada-based startup Spectral Diagnostics Inc. is developing a promising technology to decrease morbidity and mortality of patients with sepsis. The company’s proprietary technology is integrated into Toraymyxin, a hemoperfusion adsorption column which is highly effective in removing circulating endotoxin from the bloodstream. Furthermore, Spectral Diagnostics has also developed the Endotoxin Activity Assay (EAA) – the only FDA cleared, CE marked rapid diagnostic for endotoxemia. According to a company representative, in 2009 interim results of a Phase II study were published in JAMA demonstrating that “Toraymyxin, when added to conventional therapy, significantly reduced 28-day mortality in patients with severe sepsis and septic shock, compared to patients only receiving conventional therapy. Due to these positive results, that trial was terminated early and a Phase III pivotal multicenter study has been launched in the U.S. and Canada.” To find out more about this technology and its future, we had a chance to conduct an interview with Dr. Paul Walker, President and CEO of Spectral Diagnostics.

Dr. Jan Sinnige, Medgadget: Spectral Diagnostics recently started a phase three randomized controlled trial on Polymyxin B Hemoperfusion. What are the expectations according to the phase two results?

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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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Olive Medical out of Salt Lake City, Utah unveiled its HD rigid endoscope for use with the company’s fully HD camera. The endoscope is autoclavable and the company is now offering a rigid endoscope repair program that promises to repair the devices within 48 hours.

Some stated features of the endoscope from the announcement:

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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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Mimic Technologies, a company that builds the dV-Trainer, a da Vinci surgical robot simulator, recently released a software product to help assess how novice surgeons are using the simulator. The company has been collecting data from experienced surgeons performing various tasks on the simulator, and the MScore application is able to compare a novice user of the dv-Trainer against this data set to provide an overall performance score.

The hope is that with better in-silico training coupled with performance feedback, fewer animals will be sacrificed for this task, and patients will have better skilled surgeons working on them.

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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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There are more than 12 million patients globally whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications, according to Vessix Vascular (Laguna Hills, CA). Renal denervation has shown promise in treating severe drug-resistant hypertension and, by the company’s estimates, the global market opportunity for renal denervation is approaching $30 billion. The company’s V2 renal denervation system is undergoing testing in a global multi-center clinical trial.

To help the device stand out in what is becoming a crowded playing field of renal denervation players, Vessix enlisted the help of Stuart Karten Design (Los Angeles). The design firm sought to optimize the device to make the renal denervation procedure as simple for physicians as possible, eliminating complexity and clutter. The design also emphasizes the product’s aesthetics, drawing inspiration from consumer electronics. “We also wanted to celebrate the revolutionary technology with a design that flouted expectations of a boxy, plastic device,” says Anne Ramallo, manager of PR and marketing at Stuart Karten.

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