Category: Clinical TrialsSyndicate content

Weight loss: GI Dynamics' U.S. clinical trial taxes its coffers

May 20, 2013 by Arezu Sarvestani

Weight-loss devices maker GI Dynamics tells investors today that the company may seek new funding as it works to support clinical trials in pursuit of U.S. regulatory approval.

GI Dynamics logo

Investors Down Under shied away from weight-loss devices maker GI Dynamics (ASX:GID) today after president & CEO Stuart Randle told shareholders that the company may need to raise new funds in order to support its clinical trials.

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

May 17, 2013 by Ingrid Mezo

Direct Flow Medical wins FDA approval for a U.S. trial of its new transcatheter aortic valve implant.

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing enrollment in its Salus feasibility trial.

Pluristem launches Phase I clinical trial to treat tendonitis with stem cells

May 17, 2013 by Sony Salzman

Pluristem is seeking clinical proof that stem cell therapy can benefit patients with chronic tendonitis.

Pluristem Invasive Devices Inc. logo

Pluristem (NSDQ:PSTI) announced a new Phase I clinical trial to treat chronic tendonitis with the company's PLX-PAD stem cell therapy.

Cell therapy has traditionally been used in cancer and cardiac treatments, but Pluristem is now applying the technology to sports-related injuries, where it has seen an increased interest among athletes and orthopedic surgeons.

Boston Scientific hits new 52-week high on WallFlex stent trial launch

May 15, 2013 by Brad Perriello

Boston Scientific's stock price breaks the $9 barrier today on the launch of a clinical trial of its WallFlex self-expanding biliary stent.

Boston Scientific hits new 52-week high on Wallflex stent trial launch

Boston Scientific (NYSE:BSX) shares hit a new 52-week high today after the medical device company announced the launch of a clinical trial of its WallFlex biliary stent.

Valve-in-valve implantation for failed heart valves shows good short-term results

May 15, 2013 by Ingrid Mezo

Repairing failed biological heart valves with transcatheter aortic valve implants showed good short-term results, according to a study presented last week at the American Assn. for Thoracic Surgery’s annual meeting.

Valve-in-valve implantation for failed heart valves shows good short-term results

The short-term results of minimally invasive transcatheter valve-in-valve implantation to treat failed biological heart valve protheses are "excellent," but patients must be closely monitored due to some notable cases of suboptimal systolic-valve performance, according to early data from a multi-center trial.

St. Jude Medical kicks off renal denervation device study

May 14, 2013 by Ingrid Mezo

St. Jude Medical begins enrollment in the Elightn III trial of its renal denervation device for treating high blood pressure.

St. Jude Medical kicks off renal denervation device study

The 1st patient enrolled today in a St. Jude Medical (NYSE:STJ)-sponsored trial to evaluate the safety and performance of a new renal denervation system in patients with drug-resistant, uncontrolled hypertension, the company said.

Elixir goes head-to-head against Medtronic with its DESyne Nx DES study

May 13, 2013 by Sony Salzman

Elixir Medical Corporation begins enrolling patients in a new trial to compare its DESyne Nx Novolimus-eluting coronary stent system to Medtronic's equivalent.

ElixirMedical

With a green-light from the FDA, Elixir Medical Corporation will move forward with its Excella III pivotal trial to review its DESyne Nx Novolimus-eluting coronary stent system. Elixir plans to enroll patients at 50 clinical locations and will use the trial results to support its upcoming premarket approval application.

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