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Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.
Latest From Clinical Trials
In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.
ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester
Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.
Patients with HER2- metastatic breast cancer and who were tested positive for BRCA1/2 mutations with Myriad's BRACAnalysis CDx companion diagnostic showed they benefitted more from AstraZeneca's Lynparza (olaparib) than standard chemotherapy, according to results from a Phase III trial.
One-month results from the LUCY trial show that Endologix Ovation abdominal aortic aneurysm (AAA) stent graft, designed specifically for female anatomy, could make 28% more women eligible for a AAA endograft. LUCY, the first study to specifically evaluate endovascular aneurysm repair in women, is part of a trend of research focused on women's outcomes with cardiovascular devices.
REDUCE is the first trial of patent foramen ovale closure device to show statistically significant reduction in stroke recurrence in its primary intent-to-treat analysis. The results, presented at the European Stroke Organisation Conference in Prague, will support Gore's application for Cardioform to the US FDA by the end of the year.
Australian closed-loop neuromodulation specialist Saluda Medical looks to be going from strength to strength as it welcomes a $40m injection of fresh funds from investors including the GSK fund, Action Potential Venture Capital. The investment will further support Saluda's expanding clinical activities, from which positive three- and six-month data on the safety and performance of its Evoke closed-loop spinal cord stimulator were presented at the recent 13th International Neuromodulation Society congress in Edinburgh, Scotland.
A bumpy road may lie ahead for makers of high-risk implantable devices, such as neuromodulation technologies, with the advent of the EU Medical Device Regulation. Suzanne Halliday, from the notified body BSI, spoke to Medtech Insight from the International Neuromodulation Society annual meeting in Edinburgh, about key concerns with the regulation, and she offers advice to companies on how they can facilitate their transition towards the new regulatory environment.
Axonics Modulation Technologies may be running against medtech giant Medtronic in the field of sacral neuromodulation for overactive bladder, but the smaller player is unfazed. Encouraging preliminary findings from its clinical study, revealed this week at the INS 2017 neuromodulation conference, is giving Axonics' technology the validation it needs. CEO Raymond Cohen is confident that the special features offered by the r-SNM system will galvanize what is already a fast-growing market.
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