Cardiovascular

Orchestra's Drug-Eluting Balloon Wins FDA Breakthrough Device Designation

Orchestra BioMed, in partnership with Terumo, secured a breakthrough device designation by FDA for its Virtue sirolimus-eluting balloon in the treatment of below-the-knee peripheral artery disease.

Why Acutus Medical Is Turning Heads

2019 has been an exciting year for Acutus Medical, a company that Needham & Co. recently called out as an interesting private medical device company to watch.

Medtronic’s IN.PACT AV DCB Meets Primary Safety and Effectiveness Endpoints

The Dublin-based company’s clinical trial is set to follow patients with de novo or non-stented restenotic arteriovenous fistulae lesions for five years.

FDA Has Calmed Down About Paclitaxel, but Has the Market Recovered?

Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but there does seem to be some signs of a rebound in the market. The issue was a hot topic last week at Wells Fargo Securities' annual healthcare...

Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial

The Abbott Park, IL-based company has launched an IDE of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). Jason Mills, an analyst with Canaccord Genuity points out there are a handful of devices that could help define the TR repair space.

Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation

The Santa Clara, CA-based company, which raised $110 million in an IPO in March, is developing technology that uses sonic pressure waves in order to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle.

New Data Presented at ESC Congress 2019 Supports ICD Use

Late-breaking-research presented during a Hot Line Session at the European Society of Cardiology Congress 2019 shows ICD use could contribute to low mortality rates in heart failure patients.

Another Breakthrough Designation for Concept Medical

FDA granted the Tampa, FL-based company two breakthrough device designations in less than a 30-day period. Its latest designation is for the MagicTouch AVF's treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in hemodialysis treatment of renal failure.

SurModics Completes Trial Enrollment for SurVeil DCB

Enrollment completion for TRANSCEND has triggered a $10 million milestone payment from Abbott Laboratories.

Zoll’s M&A Hot Streak Continues with Cardiac Science

Zoll said it has completed the acquisition of Deerfield, WI-based Cardiac Science for an undisclosed sum.

A Smart Watch That Monitors Blood Pressure?

Biobeats has received a nod from FDA for a device that can monitor blood pressure, pulse rate, and oxygen saturation.

Adagio Gives Afib Cold Treatment in Hot Market

The Laguna Hills, CA-based company has received an IDE from FDA to initiate a clinical trial of its catheter procedure involving an energy source that freezes tissue.

New Expanded Indication Could Change the TAVR Narrative

Now Edwards and Medtronic’s transcatheter aortic valve replacement devices can be used in patients with low-risk for death or major complications associated with open-heart surgery. One analyst said the conversation will eventually shift toward TAVR being the “preferred treatment method.”

August Is Hot with New FDA Breakthrough Device Designations

Caesarea, Israel-based V-Wave has received breakthrough device designation for its Interatrial Shunt for heart failure. It is one of several companies this month to receive the designation, which is granted to devices that have the potential to offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

Nikomed Develops Recyclable Lead Wire

Made of PET and printed conductive silver ink, BioWire could replace traditional metal lead wires.

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