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Clinical Trials

Set Alert for Clinical Trials

Positive Data Give DePuy Synthes' Attune Further Knee-Up

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.

Orthopedics Clinical Trials Research & Development

Latest From Clinical Trials

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to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.

Regulation Clinical Trials

Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

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.

Starts & Stops Clinical Trials

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.

Cancer In Vitro Diagnostics

Myriad's BRACAnalysis CDx Proves Mettle In Patient Selection For AstraZeneca's Olaparib Therapy

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.

Cancer In Vitro Diagnostics

Endologix Joins Gender-Specific Movement To Target Women

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.

Cardiovascular Clinical Trials

Gore's PFO Closers REDUCE Recurrent Ischemic Strokes By 77% In Trial

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.

Cardiology Clinical Trials

INS 2017: Saluda's Closed-Loop Spinal Cord Stim Tech Sparks GSK-VC Interest; Solid Preliminary Data

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.

Financing StartUps and SMEs

INS 2017: EU MDR Will Bring Changes, But Devices With Solid Data Will Still Clear Hurdle

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.

Regulation Europe

INS 2017: Positive Initial Data Put Axonics On Next Big Wave Of Sacral Neuromodulation Growth

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.

Gynecology & Urology Clinical Trials
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