FDA Approves HeartCheck™ Pen Handheld ECG

CardioComm Solutions, Inc. has received clearance from the FDA for over-the-counter sales and marketing of their hand-held heart rhythm monitor known as the HeartCheck™ Pen Handheld ECG.

The FDA clearance also included CardioComm Solutions’ GEMS™ (Global ECG Management System) Home software, which enables the HeartCheck™ Pen to be connected to a personal computer to upload the heart rhythm recording to CardioComm Solutions’ C4 medical call service telemedicine group for review by a physician.

The HeartCheck™ Pen and GEMS™ Home solution provide an extension to the HeartCheck™ ECG Monitor solution, which may be used only under physician direction. Both devices can communicate with CardioComm Solution’s C4 medical call centre.

“Through this consumer product,” said Etienne Grima, CardioComm Solutions’ CEO, “we are truly putting people’s heart health into their own hands.” The Pen will display only the heart rate count until an interaction with a physician occurs. Once a C4 physician has provided review and feedback to the customer, the Pen’s screen can be unlocked to display the real-time ECG and heart rate count for subsequent heart rhythm recordings.

“We feel the HeartCheck™ Pen is a true remote monitoring device because it is compact, easy to use, and takes accurate heart readings in only 30 seconds. The Pen may be used from anywhere, including at home, the office, the gym or in remote areas which are often inaccessible to common ECG machines,” said Grima.

Source: BusinessWire

Barostim neo - Novel Heart Failure Implant

CVRx, Inc. has developed an implantable device called the Barostim neo for the treatment of high blood pressure and heart failure. It has been designed to trigger the body's own natural blood flow regulation by electrically activating the baroreceptors. Baroreceptors are located on the carotid artery and are the body’s natural blood pressure sensors that regulate cardiovascular function.

When activated by the Barostim neo, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion. The brain also sends signals for heart to slow down, allowing more time for the organ to fill with blood and the Kidneys are instructed to reduce fluid in the body, in turn lowering excessive blood pressure and workload on the heart.

In August 2011 CVRx received approval from authorities in major European countries and in Canada to begin the Barostim neo Trial for heart failure, and reported the first patient enrollment.

“We are pleased to report that the University of Cologne enrolled the first patient in the Barostim neo Trial for Heart Failure,” said Professor Dr. Uta Hoppe, Principal Investigator of the trial. “Our previous experience with the first-generation Barostim Therapy in heart failure was very positive, as we saw significant improvements in both cardiac structure and function. We are excited about the potential for the Barostim neo and participation in this clinical trial, which will help us better understand the impact of this novel therapy on an expanded cohort of patients with heart failure.”

Source: Press Release via Business Wire

Runkeeper Now Compatible With The Withings Blood Pressure Monitor

RunKeeper has been busy lately partnering with a number of other companies to enable their iPhone app to track everything from exercise to weight and even sleep. They have now announced that their mobile app made for tracking your exercise by GPS is compatible with the Withings Blood Pressure Monitor.

This addition extends the capabilty of Runkeeper to not only track your exercise frequency and distance, but now adds the extra metric of blood pressure. Members of Runkeeper can log into their profile and view all the running, walking or cycling history and can now keep a record of blood pressure over time. 

To use the blood pressure monitor it goes around your arm and plugs it into your iPhone/iPad/iPod. You can select to either take a single measurement or there's another mode that takes three measurements in a row to get a more accurate average. The Systole, Diastole and BPM, are then saved so you don't have to worry about manually updating your health overview from day to day.

The Withings Blood Pressure monitor has been added to our directory under Cardiology/Blood Pressure

Source: www.runkeeper.com

RDN - New Treatment for High Blood Pressure

The first use of a new minimally invasive procedure to treat high blood pressure occurred in Latin America in August 2011 in Chile at the annual meeting of Latin American Interventional Cardiologists. Called the Symplicity Catheter System^™ it accomplishes renal denervation, which is a minimally invasive procedure that uses a catheter-based probe inserted into the renal artery where high-frequency energy is emitted to deactivate the sympathetic nerves located in the renal artery walls, which in turn lowers blood pressure without drugs. (Meaning a cure for drug resistant high blood pressure)

The system consists of a generator and a flexible catheter. The catheter is introduced through the femoral artery in the upper thigh and is threaded up into the renal artery near each kidney. Once in place, the tip of the catheter delivers low-power radio-frequency (RF) energy according to a proprietary algorithm, or pattern, to affect the surrounding sympathetic nerves. The procedure does not involve a permanent implant.

The Symplicity Catheter System is already approved and commercially available in Europe and Australia, however is still under investigational use in the US and is not approved for sale there. 

Medronics new blood pressure system has been added to our directory here under cardiology/blood pressure.

Source - Medtronic press release via BusinessWire