A Medical Device Daily

Misonix (Farmingdale, New York), a maker of ultrasonic medical device technology, has entered into a three-year, exclusive distribution agreement with Martin-Medtechnika (Moscow), doing business as EuroTech. EuroTech will distribute the SonaStar ultrasonic surgical aspirator, the BoneScalpel ultrasonic bone cutter and the SonicOne ultrasonic wound debrider. The agreement provides EuroTech with the rights to sell throughout the Russian Federation and includes annual minimum purchase requirements. Open market sales will commence after product registration with the Ministry of Health.

The SonaStar is used by neuro and general surgeons for removal of both hard and soft tumors while sparing most vessels. In addition, OsteoSculpt bone sculpting technology can be used with the SonaStar to safely remove osseous structures, thus providing access to the surgical site.

The BoneScalpel is a tissue specific osteotomy device capable of making precise cuts through bone and hard tissue while largely preserving delicate soft tissue structures. It offers the convenience and speed of a power instrument without the danger associated with rotary sharps.

The SonicOne is an ultrasonic wound care system that offers tissue-specific debridement and cleansing for effective removal of devitalized tissue and fibrin deposits while sparing viable cellular structures.

“Misonix is excited about adding 'EuroTech' to our growing family of specialty distributors. Their reputation as a leading distributor of medical equipment in the Russian Federation is well known to us,“ said Michael McManus, Jr., president/CEO of Misonix. “Their commitment to service, as well as their success in introducing high tech medical devices, was appealing to Misonix. We are particularly pleased that they will be selling three of our key products through their extensive distribution network.“

Medtronic's Resolute stent gets CE mark

Medtronic (Minneapolis) reported the CE mark and international launch of the Resolute Integrity stent system for the treatment of coronary artery disease.

Medtronic says the Resolute stent features a drug-eluting coronary stent with superior deliverability – the ability of the device to traverse the patient's vasculature and reach the blockage in the heart artery. Based on the engineering advance of continuous sinusoid technology, the Resolute has been shown in bench testing and in blinded in vivo physician assessment studies to be significantly more deliverable than the current market-leading alternatives, the company said.

“Medtronic stents built on continuous sinusoid technology are noticeably more deliverable, giving me greater confidence that I can reach the target lesion, even in patients with especially tortuous anatomy or narrow vessels,“ said Neal Uren, MD, consultant cardiologist at Lothian University Hospitals NHS Trust, Royal Infirmary of Edinburgh, and honorary senior lecturer at the University of Edinburgh, in Scotland.

The Resolute stent combines continuous sinusoid technology with two elements of the original Resolute DES: the cytostatic antiproliferative drug zotarolimus and the biocompatible BioLinx polymer.

Lab21 licensed in South Carolina

Lab21 (Cambridge, UK) has entered into an exclusive global license from the Medical University of South Carolina's (MUSC; Charleston) Foundation for Research Development which allows the detection and analysis of genetic variants of the human carboxylesterase-1 gene (CES-1). CES-1 is a gene which influences how the body metabolizes certain treatments, and can have a significant effect on the effectiveness of therapeutic drugs, making genetic screening a valuable clinical tool in predicting patient response, and ensuring the optimum treatment.

Lab21 will offer CES-1 analysis from both of its service laboratories in Greenville, South Carolina and Cambridge and will also be developing commercial diagnostic kits through its diagnostic products division. These kits will be sold to pathology laboratories throughout the world. Financial terms of the deal were not disclosed.

Natural genetic variants of the CES-1 gene can have profound effects on the way in which the body metabolizes specific drugs including representative drugs from almost every therapeutic class. Consequences of the presence of these variants include the inability of the body to properly utilize the drug, potential for unanticipated toxicities, and overall therapeutic failure in treating the targeted disease or disorder.

“The acquisition of this license is another step towards Lab21 becoming a leading global provider of diagnostic services and products in the personalized medicine arena. Pharmacogenetics and companion diagnostic services are becoming an integral part of modern medicine. Detailed understanding of the ways that the body manages pharmaceuticals is a major factor in the drug development process. The introduction of CES-1 analysis adds another component to the growing arsenal of pharmacogenetic tests which can assist in optimized personalized medicine,“ said Berwyn Clarke, chief scientific officer of Lab21.

BD launches micro injection pen in UK

Becton Dickinson (BD; Franklin Lakes, New Jersey), reported the launch of BD Micro-Fine+ 4 mm pen needle. BD claims this needle is proven to be as effective as longer needles for patients of all body types and proven to offer a less painful injection experience for the estimated 800,000 people in the UK with diabetes using injectable therapies. As many as 2.75 million people in the UK now have diabetes, a total that is forecast to climb to four million by 2025.

Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety. Patients who reported injection-related pain or embarrassment intentionally skipped insulin injections more often. The short length (4 mm) and thin gauge (32 G) of the BD Micro-Fine+ pen needle may help people with diabetes adhere to an insulin injection regimen and improve outcomes.

Ascension's PyroTitan implanted in UK

Ascension Orthopedics (Austin, Texas) reported the implantation of the first PyroTitan humeral resurfacing implant in the UK. The PyroTitan was implanted at BMI – The Alexandra Hospital (Cheadle, UK).

The PyroTitan offers a conservative, bone-sparing option for patients in need of shoulder joint replacement. PyroTitan is available in 12 sizes, which are based on published anthropomorphic data of more than 300 human humeri to provide an improved anatomic fit. Cartilage and bone-friendly PyroCarbon have the potential to reduce pain caused by wear of traditional metal implants as well as the chance to extend the longevity of the hemiarthroplasty joint replacement.