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FSS lands extended CE Mark for FlexStent | Regulatory Roundup

June 29, 2012 2:21 pm | by Mass Device | News | Comments

Flexible Stenting Solutions touts CE Mark approval for additional sizes of its FlexStent self-expanding iliac stents.  FSS touts CE Mark win for new self-expanding stent sizes News Well, 510(k), CE Mark, Food & Drug Administration (FDA), Regulatory Roundup, Regulatory/Complianceread more

Applying Tech: Cardiovascular

June 27, 2012 5:38 pm | Articles | Comments

How are you influencing cardiovascular devices?

FDA approves SonixGPS needle guidance technology for vascular access procedures

June 26, 2012 5:49 am | News | Comments

Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.


Pitt Develops Biodegradable Artery Graft to Enhance Bypass Surgeries

June 25, 2012 10:58 am | News | Comments

With the University of Pittsburgh’s development of a cell-free, biodegradable artery graft comes a potentially transformative change in coronary artery bypass surgeries: Within 90 days after surgery, the patient will have a regenerated artery...

Cook Medical Sponsors First Clinical Study to Examine New Endovascular Technique

June 25, 2012 10:30 am | News | Comments

Clinical investigators are for the first time examining the retrograde tibiopedal interventional approach, an endovascular technique that has the potential to reduce the rate of leg amputations by as much as 50 percent in patients with critical limb ischemia...

Discovery of ‘Master Molecule’ Could Improve Stem Cell Treatment for Heart Attacks

June 25, 2012 7:34 am | News | Comments

Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, a finding that may lead to better ways to treat heart attack patients.

Penumbra Inc. Launches the New MAX System Reperfusion Catheters for Acute Ischemic Stroke Patients

June 19, 2012 6:03 am | News | Comments

The Penumbra System® family of aspiration thrombectomy devices now includes the MAX System of Reperfusion Catheters for removal of clots in patients experiencing acute ischemic stroke. The MAX System neuro-interventional devices offer a fast, simplified...

CardiAQ Valve Technologies Reports Cardiovascular Medicine Milestone: First-in-Human Nonsurgical Percutaneous Implantation of a Bioprosthetic Mitral Heart Valve

June 15, 2012 6:01 am | News | Comments

CardiAQ Valve Technologies (CardiAQ), which has developed the world’s first self-conforming and self-anchoring technology for nonsurgical Transcatheter Mitral Valve Implantation (TMVI), today announced that the Company has achieved a cardiovascular medicine milestone...


STENTYS Starts Clinical Trial to Broaden Portfolio with New Drug-Eluting Stent

June 15, 2012 5:56 am | News | Comments

STENTYS S.A. (STNT.PA), a medical technology company commercializing the world's first and only Self-Apposing® Stent to treat Acute Myocardial Infarction (AMI), announced today that it has enrolled the first patient in its ‘APPOSITION IV’ clinical study...

Tiny Robots Mend Broken Hearts

June 8, 2012 12:35 am | by Massachusetts Institute of Technology | News | Comments

Millimeter-scale devices could give surgeons the ability to operate on beating hearts.

Medtronic Launches Endurant II AAA Stent Graft System in U.S.

June 7, 2012 7:55 am | News | Comments

Medtronic, Inc. has announced the U.S. launch of the Endurant® II AAA Stent Graft System, which recently received approval from the U.S. Food and Drug Administration (FDA) for the minimally invasive treatment of abdominal aortic aneurysms through endovascular repair...

Welch Allyn Donates Devices to Program that Helps Raise Awareness of Hypertension Among African Americans

June 6, 2012 6:15 am | News | Comments

Welch Allyn, a leading global provider of frontline medical products and solutions, today announced it has donated 50 Spot Vital Signs® devices to the American Methodist Episcopal Church (AMEC) Connectional Health Commission’s program, “Manage BP with AMECHealth.”

Vena cava filters do not lower mortality rate in most embolism cases

June 1, 2012 6:41 am | News | Comments

A filter used to block clots from passing from the veins in the legs to the arteries of the lung does not improve mortality rates for most patients suffering a pulmonary embolism. However, if a patient is unstable – in shock or requires a ventilator – filters can save lives.


Custom Laser Job Shop Services

May 18, 2012 10:43 am | Laserage Technology Corporation | Product Releases | Comments

The stent material, cutting techniques, finishing techniques, and inspection techniques are integral to a quality medical stent. Careful customization is required with these processes...

A North American first at the Montreal Heart Institute

May 18, 2012 7:10 am | News | Comments

The surgical team at the Montreal Heart Institute (MHI) achieved a North American surgical milestone on May 1st with a sutureless aortic valve replacement through a thoracic incision just five centimetres long. The two patients in their seventies who underwent this innovative...

PROMUS Element Stent Demonstrates Excellent Long-Term Safety and Effectiveness in PLATINUM Small Vessel Study

May 18, 2012 6:55 am | News | Comments

Boston Scientific Corporation announces two-year results from the PLATINUM Small Vessel study, demonstrating excellent safety and effectiveness outcomes for the 2.25 mm PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr) Stent System...

BiO2 Medical Granted CE Mark for the Angel Catheter, the First IVC Filter with a Prophylactic Use Indication

May 15, 2012 12:23 pm | News | Comments

BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, announced today that it has received CE Mark approval for the Angel™ Catheter, a Nitinol Inferior Vena Cava...

Medtronic Nets New Indications for Resolute Integrity Drug-Eluting Stent in Europe

May 15, 2012 11:57 am | News | Comments

As EuroPCR 2012 gets under way today, Medtronic, Inc. announced that the Resolute Integrity Coronary Stent System has received European regulatory approval for several new indications, making it the drug-eluting stent (DES) with the broadest range of approved indications...

Boston Scientific Announces Positive Data From Lotus Transcatheter Aortic Valve Trial

May 15, 2012 11:43 am | News | Comments

Boston Scientific Corporation announces results from the REPRISE I feasibility trial, which evaluated the acute safety of the Lotus™ Aortic Valve System in patients with severe aortic valve disease.  The Lotus Aortic Valve System is the first transcatheter aortic valve replacement...

Increasing Use of Smart Pumps to help drive down 'Never Events'

May 15, 2012 5:35 am | News | Comments

Increased focus on providing optimum patient care in the most cost efficient way is fuelling demand for intelligent infusion devices termed “Smart Pumps.” A report from InMedica, a division of IMS Research (recently acquired by IHS Inc.), on the global market...

Study Shows Robotically Enhanced PCI IS Safe and Feasible for Many Patients

May 14, 2012 5:04 am | News | Comments

A robotic system can safely assist interventional cardiologists in performing percutaneous coronary interventions (PCI) while significantly reducing the physician's exposure to radiation and improving precision and control, according to results of the PRECISE study...

Study of First-in-Class Watchman Device Shows 75% Reduction in Stroke Risk in Patients with Atrial Fibrillation not Eligible for Oral Anticoagulation Therapy

May 14, 2012 4:58 am | News | Comments

Boston Scientific Corporation announces results from the ASA Plavix (ASAP) Study, which studied the WATCHMAN® Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation...

Interrad Medical Announces FDA Clearance for Additional Sizes of the SecurAcath Device

May 10, 2012 5:57 am | News | Comments

Interrad Medical, Inc. a privately held medical device company, announced today that it has received FDA clearance for four new sizes of the SecurAcath subcutaneous catheter securement device. In response to requests from clinicians throughout the US, Canada and Europe...

Sorin Group Announces FDA Approval and Commercial Launch of Complete Portfolio of Implantable Heart Device Leads

May 10, 2012 5:54 am | News | Comments

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd Annual Scientific Sessions, FDA approval and commercial launch for a full portfolio of pacing...

Nitto Denko Obtains US Patent for Antifibrotic Therapies with Molecular Targeting DDS Technology

May 10, 2012 5:48 am | News | Comments

Japan's leading diversified materials manufacturer, Nitto Denko Corporation, today announced that a basic patent regarding the company's epoch-making antifibrotic therapy has been successfully registered in the USA. Nitto Denko has been developing antifibrotic drugs...

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