Category: Clinical TrialsSyndicate content

CorMatrix wins FDA nod for tricuspid valve trial

March 4, 2015 by Mark Hollmer

CorMatrix Cardiovascular wins an investigational device exemption from the FDA for a small feasibility study of its new tricuspid valve replacement.

CorMatrix wins FDA nod for tricuspid valve trial

Georgia's CorMatrix Cardiovascular said this week that it plans to enroll up to 15 pediatric and adult patients in a feasibility study of its new tricuspid valve replacement device.

Tryton Medical's pivotal trial misses endpoint

March 2, 2015 by Brad Perriello

A pivotal trial of Tryton Medical's side-branch stent fails to meet its non-inferiority endpoint for target vessel failure, although most of the patients in the study fell outside its target parameters.

Tryton Medical's pivotal trial misses endpoint

A pivotal clinical trial of Tryton Medical's side-branch stent, the largest ever conducted on coronary bifurcation lesions, failed to meet its primary endpoint for target vessel failure.

Epilepsy: Medtronic touts 5 year results on SANTE trial

February 23, 2015 by Mark Hollmer

Medtronic’s DBS therapy for treatment-resistant epilepsy has produced long-lasting improvements in quality of life after 5 years, according to detailed results from a pivotal clinical trial.

Medtronic CFO Ellis: Covidien deal frees up 25% more cash

Diabetes: CeQur touts study showing improvement in glycemic control

February 20, 2015 by Mark Hollmer

CeQur SA is touting preliminary results from study that evaluates long-term glycemic control produced by its wearable insulin delivery device.

Diabetes: CeQur closes $27B Series B round

CeQur SA, developer of a 3-day, wearable insulin delivery device, is touting promising preliminary results from a new study evaluating its glycemic control over three months.

The Horw, Switzerland-based company, said that early data from the trial shows its PaQ device consistently improved glycemic control in patients with type 2 diabetes. That conclusion comes from a single-arm treat-to-target 12-week pilot study involving eight people with the condition.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA OKs Sequent Medical trial for Web aneurysm device

February 13, 2015 by Mark Hollmer

Sequent Medical wins an FDA nod for an investigational device exemption trial of its Web aneurysm embolization device.

FDA OKs Sequent Medical trial for Web aneurysm devicwe

Sequent Medical armed itself last April with $20 million in venture cash earmarked for a U.S. IDE trial involving its Web aneurysm embolization device. Ten months later, it has the regulatory O.K. to proceed with the study.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Diabetes: Medtronic touts post-market MiniMed 530G data

February 13, 2015 by Mark Hollmer

Medtronic says a post-marketing study involving 20,000 people using its MiniMed 530G insulin pump showed an automated feature reliably helped reduce hypoglycemia levels.

Medtronic touts post-market MiniMed 530G data

Medtronic (NYSE:MDT) yesterday touted a 20,000 -patient post-market study iasserting the success and durability of its MiniMed 530G insulin pump.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

FDA OKs 2nd phase for Presbia's Flexivue Microlens pivotal

February 13, 2015 by Val Kennedy

Presbia receives FDA clearance to enroll patients in the 2nd stage of a pivotal study of its Flexivue Microlens for treating presbyopia.

FDA OKs 2nd phase for Presbia's Flexivue Microlens pivotal

Get the complete picture with a MassDevice Plus membership. Registered users can login here.

Preferred Vendors

Phase 2 Medical Manufacturing, Inc
Provides design, development, manufacturing, packaging, shipping, and sterilization services.
SMC Ltd. (Scientific Molding Corp.)
Manufactures injection-molded, single-use disposable medical devices
CB Set: Concord Biomedical Sciences and Emerging Technologies
Provides research support for all phases of biomedical discovery and development research.
Emergo Group, Inc.
Regulatory charts and consulting
Tegra Medical
Provides contract manufacturing and assembly services
GW Plastics Inc.
Provides injection molding services
Admet
Static and Dynamic testing systems for materials, components, and devices. Systems range from 50 grams to 600kN of force capacity in tension, compression, torsion, and more.
Provides grips, fixtures, heating and cooling systems, and fluid baths.
Interface Catheter Solutions
Balloon Catheters
STERIS Isomedix Services
Provides sterilization and validation services using gamma irradiation, ethylene oxide and steam sterilization technologies through 19 North American locations
AdvancedCath
Finished Guidewires, Catheters as well as extrusions, catheter shafts and medical balloons
Resonetics
Polymer Micromachining