A BB&T Staff Report

Micell Technologies (Durham, North Carolina) said it has enrolled at Mercy Hospital (Auckland, New Zealand), the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-man clinical trial of the company's investigational MiStent drug eluting coronary stent system (MiStent DES).

DESSOLVE I is a prospective, open-label, non-randomized, single-arm study that is expected to enroll 30 patients at five clinical sites in Belgium, Australia and New Zealand. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia. The primary endpoint is in-stent late lumen loss, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 mm to 3.5 mm and amenable to treatment with a maximum 23 mm long stent.

Along with secondary clinical endpoints such as major adverse cardiac events and revascularization rates, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) will also be employed at multiple timepoints. The DESSOLVE I study uses multiple imaging modalities to better understand the time to complete tissue coverage of the stent struts relative to polymer absorption.

“Drug-eluting stents represent a significant advance in interventional cardiology,“ said John Ormiston, MD, of Mercy Hospital and co-principal investigator. “However, the rare but potentially catastrophic consequences of late in-stent thrombosis remain to be addressed. The MiStent DES is designed to maintain the polymer-drug matrix on the stent only as long as drug delivery is required. It slowly reverts to a bare-metal stent by the time that drug treatment is completed. These are exactly the properties that interventional cardiologists are looking for in a drug-eluting stent.“

The MiStent DES employs Micell's supercritical fluid technology that applies a precisely controlled bioabsorbable polymer — active drug (sirolimus) matrix onto a cobalt-chromium stent. The polymer dissolves and releases the drug into the surrounding tissue in a controlled manner, designed to optimize dosing of the drug throughout the affected artery. In pre-clinical trials, the drug completely elutes and the polymer is eliminated within 90 days in vivo resulting in a bare metal stent.

Trabecular Cup earns high reimbursement in Japan

Zimmer (Warsaw, Indiana) reported last month that the Trabecular Metal Modular Cup has received the distinction of being awarded the highest reimbursement premium percentage granted to-date for an orthopedic product in Japan.

The Japanese Central Social Insurance Medical Council, otherwise known as the Chuikyo, awarded Zimmer's trabecular metal modular cup with what the company claimed was an unprecedented 20% reimbursement premium. The decision was presented by the Chuikyo expert panel after a comprehensive review of both the material technology and clinical data. It was the opinion of the expert panel that the extensive positive clinical data clearly demonstrated significant clinical advantages and effectiveness of Zimmer's trabecular metal technology. Based on the review, a new functional reimbursement category has been established in Japan for the Trabecular Metal Modular Cup and will be introduced this month.

Trabecular metal material is a highly porous biomaterial that resembles the structure, function, and physiology of trabecular bone.

EDAP system gets South Korean FDA approval

Therapeutic ultrasound developer EDAP (Lyon, France) reported the approval of its new lithotripter Sonolith i-move by the South Korean Food and Drug Administration (KFDA).

South Korea is the second largest market in Asia for lithotripsy devices after Japan. EDAP has one of the largest lithotripter installed bases in South Korea, with more than 50 fully installed devices.

EDAP develops Ablatherm, which uses high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.

Smiths receives Canadian license

Smiths Medical (St. Paul, Minnesota) said it received a license from Health Canada and launched its Medfusion 4000 syringe infusion pump with the PharmGuard software suite in Canada. The Medfusion 4000 pump includes enhanced and user-friendly features based on clinician usability input, including wireless (802.11b/g) and wired Ethernet capability to allow connections to the PharmGuard server software. The PharmGuard server software is installed at a hospital's site and communicates with Medfusion 4000 pumps to collect infusion device data to help determine patient compliance with therapies.

Lab21 reports securing new U.S. and Euro patents

Lab21 (Cambridge, UK), a specialist in personalized medicine, has secured new patents in Europe and the U.S. relating to Hepatitis C and its SelahDOTS fluorescent nanoparticles, as it continues to expand its intellectual property portfolio. The hepatitis C patent extends an existing patent, and refers to technology allowing the genotypic identification of drug-resistant mutations in the 4 major global genotypes of HCV. With the imminent launch of a series of new small molecule therapies in HCV, this technology will allow accurate monitoring of when drug resistance appears in individual patients, improving patient care.

The SelahDOTS nanoparticles technology covers a generic approach to the development of new diagnostic and imaging reagents using carbon-based non-toxic nanoparticles. This platform technology has multiple applications in clinical diagnostics and was originally developed through a license from Clemson University (Clemson, South Carolina). The grant of the patent now allows Lab21 to develop a series of new product and service applications in areas such as in vivo imaging, immunodiagnostics and point-of-care biomarker analysis,

The securing of these patents builds on Lab21's growing intellectual property portfolio as it expands its competitive position in pharmacogenetic markers, disease markers and its assay technology, the company said.

Stentys reports initiation of APPOSITION III

Stentys (Princeton, New Jersey/Paris), a company that develops stents to treat acute myocardial infarction (AMI), reported last month that it has begun the international APPOSITION III study of its self-apposing stent, with 50 patients already enrolled out of a total of 500. The trial's primary endpoint is major adverse cardiac events at 12 months post-procedure.

“The cardiologists in our cath lab are extremely excited to be part of the APPOSITION III study, because it allows us to use the STENTYS self-apposing stent in a real-life setting for the treatment of AMI patients,“ said study investigator Harald Mudra, MD, PhD, head of the Department of Cardiology, Pulmonology and Internal Intensive Care Medicine at the Neuperlach Hospital (Munich, Germany).

“Based on the results of APPOSITION I and II, the clinical evidence is indisputable: malapposition, which is a known cause of early stent thrombosis and repeat AMI, can be eliminated with the use of our self-apposing stent. APPOSITION III, designed as a large scale single-arm prospective clinical study, will confirm that the Stentys stent is the solution for the treatment of heart attack patients,“ added Gonzague Issenmann, CEO and co-founder of Stentys.

The company believes the Stentys stent represents a major breakthrough compared to conventional stents when treating heart attacks: it is self-apposing, i.e. it “fits snugly“ into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase.

The APPOSITION II randomized trial compared the Stentys self-apposing stent with a conventional stent in patients suffering a heart attack. It showed that, three days after an AMI, 28% of patients treated with conventional stents displayed significant malapposition, meaning that the stent was not completely in contact with the artery wall. Malapposition puts AMI patients at significant risk of potential fatal complications such as a blockage of the stent (in-stent thrombosis). In contrast, none of the patients treated with the Stentys stent had stent malapposition.

CoreValve gains CE mark for new implantation

Medtronic (Minneapolis) has received the CE mark for the CoreValve system to be delivered through a novel approach, which would allow access through the subclavian artery located beneath the collar bone. As a result, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI). Since 2007, the CoreValve system has been implanted in more than 12,000 people in 34 countries. The system is currently limited to investigational use in the U.S.

The CoreValve is designed to provide a non-surgical aortic valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open-heart surgery. Transcatheter valves are typically implanted through the femoral artery in the leg. However, there are thousands of people whose femoral arteries are too narrow or are compromised due to disease.

ArthroCare's WoundWand wins CE mark

ArthroCare (Austin, Texas) reported that its WoundWand debridement device is CE marked and is available for distribution in Europe. Using ArthroCare's patented Coblation technology, the WoundWand enables necrotic tissue to be removed from a wound in a precise and controlled manner.

The WoundWand is intended for wound debridement in acute and chronic wounds and wound cleansing by removal of necrotic tissue.

Ellipse Precice system garners the CE mark

Ellipse Technologies (Irvine, California) said it has received the CE mark for its Precice limb lengthening device. Limb lengthening procedures are used to treat a number of medical conditions, including shortened legs due to congenital abnormalities, major fractures of one of the legs and shortened leg bones due to other medical diseases, such as cancer.

The Precice devices are unique intramedullary rods which provide physicians with a new method of treating these conditions. Rather than using adjustable external fixation systems which are attached to the leg bone through long-term openings in the skin, the Ellipse device uses the Precice Remote Control Technology, an internal implant adjusted to lengthen the leg bones via non-invasive methods from outside the body. Ellipse and its scientific advisors believe the Precice devices will not only provide a less-invasive approach to these procedures but also significantly reduce the potential for complications (e.g., infections) during the healing period.

Ellipse will complete a multi-center international clinical study using the Precice devices by mid-2011. An international product launch in countries that accept CE-mark approval will be implemented during the second half of 2011. Ellipse is continuing to develop additional Precice devices for other orthopedic fracture management applications.

Hutchinson gets CE mark for InSpectra test

Hutchinson Technology (Hutchinson, Minnesota) has received the CE mark for its InSpectra StO2 Spot Check for use as a noninvasive, cost-effective tool to rapidly assess the tissue oxygenation of patients in circulatory distress. The product, which is targeted for use in emergency and critical care environments, is now available in countries that recognize the CE mark. The company also has filed for marketing clearance of the product in the U.S.

The InSpectra StO2 Spot Check (model 300) consists of a hand-held device, cable, reusable sensor, charging station and rechargeable battery. These features enable clinicians to identify at-risk patients, who can then be continuously monitored with the InSpectra StO2 Tissue Oxygenation Monitor (model 650). Used together, these two products help reduce the time to critical actions and help identify the endpoints of resuscitation, the company said.

Companies launch cancer testing service in Canada

Epigenomics (Berlin), a cancer molecular diagnostics company, and Warnex Medical Laboratories (Laval, Quebec) reported the launch of a molecular diagnostic blood testing service for colorectal cancer in Canada, based on Epigenomics' biomarker Septin9 and DNA methylation technologies. Warnex is the first laboratory to offer Septin9 testing in Canada, after obtaining the non-exclusive rights from Epigenomics in May. Prior to its launch, Warnex's Septin9 test was independently developed and validated using clinical blood samples from colorectal cancer patients and individuals with no apparent disease as verified by colonoscopy.

Grifols, Health Robotics plan I.V. room of the future

Health Robotics (Bolzano, Italy) said it has signed an exclusive cooperation agreement for Grifols (Barcelona, Spain) to significantly contribute to its I.V. Room of the Future initiative with its Misterium clean room products and I.V. therapy and clinical nutrition knowledge and experience.

The agreement also includes the appointment of Grifols' scientific expert Oriol Prat as an additional member of Health Robotics' scientific advisory board.

“Grifols has designed and constructed more than 1.2 million square feet of clean rooms worldwide and managed more than 150 modular clean room installations at hospitals. After witnessing the outstanding combined results of the joint implementation of Misterium and i.v.Station at Vall d'Hebron University Hospital in Barcelona, I was convinced that global hospitals stand to greatly benefit from the synergies between the respective companies' experience, products, and services within the I.V. Room Technology sector,“ said Gaspar DeViedma, Health Robotics' executive VP.

NKI gets license to sell 3 products in Canada

Neuro Kinetics (NKI; Pittsburgh), manufacturer of noninvasive medical diagnostic equipment used to test for vestibular and neurological conditions, said last month it has been granted a license from Health Canada to sell three of its devices in Canada for clinical use.

The company previously had sold its equipment in Canada for research purposes only.

The three NKI devices now approved for clinical use by Health Canada's Health Products and Food Branch (HPFB) are its I-Portal NOTC (Neuro-Otologic Test Center) system, I-Portal VNG (Video Nystagmography) system and I-Portal VOG (Video Oculography) system, along with related accessories, software, training and support services.

NKI also said last month it has appointed Canadian medical device distributor AIM Instrumentation & Technologies as its sole representative in Canada. AIM has offices in Mississauga, Ontario, and Burnaby, British Columbia.