Medgadget » Cardiology

Analogic Releases New BK Medical Ultrasounds

Gene Ostrovsky — Wed, 08 Feb 2012 16:39:19 +0000

Analogic has announced the worldwide launch of three new ultrasound systems from its subsidiary BK Medical, the Pro Focus UltraView 800, the Flex Focus 800, and the Flex Focus 500.

All three models sport the company’s “Quantum Technology” that provides high resolution visualization of the tissues.

Boston Sci’s PROMUS Element Plus PtCr Stent Debuts in Europe

Brian Klein — Thu, 02 Feb 2012 21:45:34 +0000

Bostton Scientific has announced the European market launch of the PROMUS Element Plus everolimus-eluting platinum chromium coronary stent. Professor Antonio Colombo, MD, director of the cardiac catheterization lab at Columbus Hospital and San Raffaele Hospital in Milan, recently implanted the first patient in Europe with the device. The stent incorporates platinum chromium (PtCr) alloy and features a catheter delivery system designed to facilitate deliverability in treating patients with coronary artery disease. Boston Scientific plans on marketing the stent in select European and other CE Mark countries immediately. A full market launch will follow in the second quarter of 2012.

“The PtCr alloy and stent architecture used in the Element platform offer significant advantages in conformability and radiopacity compared to other stent platforms,” explained Dr. Colombo in a press release. “I believe the improved deliverability of the PROMUS Element Plus Stent System will add another significant benefit, especially when accessing challenging lesions. This innovative stent is also supported by strong clinical outcomes from the PLATINUM trials, which demonstrated very low rates of revascularization and stent thrombosis at one year.”

Edwards Lifesciences Announces Promising Transcatheter Patient Data

Brian Klein — Thu, 02 Feb 2012 02:19:16 +0000

Edwards Lifesciences has announced that a recent clinical trial studying its Sapien transcatheter heart valve found reduced mortality rates in high-risk patients with severe aortic stenosis.

A recent press release explains that patients in the trial were treated with transapical transcatheter aortic valve replacement (TAVR) during the continued access period of Cohort A of The PARTNER Trial. The findings on the Edwards SAPIEN transcatheter heart valve were announced at The Society of Thoracic Surgeons’ (STS) annual meeting in Ft. Lauderdale, FL.

Medtronic DF4 High-Voltage Connector System Green Lighted in U.S.

Gene Ostrovsky — Wed, 01 Feb 2012 21:02:43 +0000

Medtronic received FDA clearance for its DF4 High-Voltage Connector System, a right ventricular lead and connector, compatible with various implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The device is made to be easier to implant thanks to a new port featuring visual confirmation and only one connection unlike previous leads that often needed up to three hookups.

CardioKinetix Receives Expanded CE Approval for Parachute Percutaneous Left Ventricular Partitioning Device

Wouter Stomp — Tue, 31 Jan 2012 20:41:42 +0000

CardioKinetix has developed a novel transcatheter implant called Parachute Ventricular Partitioning Device, which already received the CE mark and has now won approval for two additional sizes. The Parachute is a partitioning membrane deployed within the compromised ventricle that is intended to treat heart failure resulting from myocardial infarction.

The Parachute consists of a synthetic fluoropolymer (ePTFE) membrane stretched over a nitinol frame. The idea behind the device is that it partitions the damaged muscle, isolating the non-functional muscle segment from the functional segment, which decreases the overall volume and restores a more normal geometry and function in the left ventricle.

Spiro PD Personal Spirometer for Lung Function Analysis

Gene Ostrovsky — Tue, 24 Jan 2012 22:00:17 +0000

PMD Healthcare has released its new portable spirometer that allows people with all kinds of lung conditions, like asthma, COPD and cystic fibrosis, to monitor their lung function. The device can also provide reminders to take medications and perform tests, as well as to be used to conduct breathing exercises.

Data from the device can be uploaded via a computer for physicians to be able to analyze results over time.

FDA Grants IDE Nod to Innovative High Blood Pressure Device

Brian Klein — Tue, 24 Jan 2012 20:11:54 +0000

The FDA has conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate a new patented isometric handgrip therapy technology. A product of Zona Health (Boise, ID), the ZonaRx device was developed for use in the treatment of resistant hypertension (high blood pressure that persists despite treatment by two or more medications). The IDE approval marks the first pivotal trial of isometric handgrip therapy for hypertension treatment.

Earlier clinical studies demonstrate that the isometric handgrip therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive patients,” according to Zona Health. According to earlier data, 135 out of 136 study participants achieved significant blood pressure drops in eight weeks or less.

St. Jude Medical’s FAME II Trial Halted Due to Positive Results

Paul Pisklak — Mon, 23 Jan 2012 19:39:59 +0000

In the world of coronary artery disease treatment, if you blink, you will miss the latest development, so stent your eyes open for this latest piece of the puzzle. The latest question that keeps getting a new answer with every study is whether optimum medical therapy (OMT) or percutaneous coronary interventions (PCI) provides the best results for patients with coronary artery disease. With the introduction of fractional flow reserve (FFR) technology, the question had to be asked anew.

In case you haven’t heard of it, FFR is an index that compares the pressure proximal to a coronary artery obstruction to the pressure distal to that obstruction. In other words, it measures how much a given lesion actually impairs flow to the myocardium. Previously, the decision about whether to stent a given vessel was more subjective, and lesions that looked “suspicious” on angiograms were stented. FFR gives a more objective component to this judgment, and it was hoped that this would improve outcomes.

Ivera Medical’s Curos Port Protector Gets Expanded FDA Clearance

Gene Ostrovsky — Mon, 23 Jan 2012 16:58:59 +0000

Ivera Medical Corporation out of San Diego, CA received a new FDA 510(k) clearance for its Curos disinfecting port protector, after the company confirmed a shorter disinfection time and an increase in how long the device can be used.

According to the company, independent tests have shown that the cap disinfects IV access ports in three minutes, keeping them clean for seven days when not accessed.

HeartCheck Pen Handheld ECG for At-Home Cardiac Monitoring

Gene Ostrovsky — Fri, 20 Jan 2012 23:32:54 +0000

CardioComm out of Victoria, Canada received marketing clearance from the FDA to bring its HeartCheck Pen Handheld ECG to the U.S.

The device can be used by the patients themselves at home and comes with software the allows recorded telemetry to be uploaded to the company’s C4 medical call service telemedicine group where physicians can analyze the data.