Medical Device Dailys
Siemens Healthcare (Erlangen, Germany) is celebrating the 500th installation of a Somaton dual-source computed tomography (CT) scanner that was introduced less than four years ago.
A novel feature for CT diagnostic imaging unique to Siemens, the company interprets the strong sales of dual-source scanners as proof of its acceptance and adoption by the medical community.
As major competitors in radiology have raced to expand the size of arrays of detectors to render greater detail and faster captures, Siemens bet on two X-ray tubes instead, creating different, and, according to Sami Atiya, CEO of CT at Siemens, superior images.
"We turned our backs on this competition for detector size," he said, "as an additional increase in the number of detector rows would not have succeeded in satisfying future clinical requirements."
The development of the Straton X-ray tube by Siemens in 2000 provided the inspiration for doubling down on the bet.
It was previously impossible to place two X-ray tubes in a single CT scanner due to their bulky dimensions, Atiya said.
Half the size and significantly lighter than conventional tubes, the Straton tube made it possible to arrange two X-ray tube assemblies and two detectors in the gantry.
Doubling the speed of a scan with dual-source CT enabled the Somaton units to capture a highly detailed image of a heart, literally, in a heartbeat, during the diastolic phase.
A second benefit was cutting the radiation dosage in half.
Later product development included generating different levels of energy simultaneously creating new data sets for diagnostic imaging that provide vivid renderings for tissue characterization and perfusion analysis opening new clinical applications for CT.
Siemens currently offers a line of 10 dual-energy CT applications used to diagnose diseases of the heart, brain and lungs as well as skeletal structures.
Siemens recently extended the high end of its portfolio with the Somatom Definition Flash, capable of scanning the entire heart in less than half a heartbeat while also reducing the radiation dose to less than 1 millisievert, compared to an average effective dose for heart scans from 8 mSv to 30 mSv.
CE mark for ThromCat XT system
Spectranetics (Colorado Springs, Colorado) reported receiving CE-mark approval for its next-generation ThromCat XT Thrombus Removal System, a single-use, disposable device indicated for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries. The launch of the product will commence immediately within the European Union.
The approval triggers a milestone payment of $1.5 million under the company's development agreement with Kensey Nash (Exton, Pennsylvania).
The ThromCat XT System is an improvement to the current ThromCat System with enhanced thrombus removal and several advancements in ease-of-use. The ThromCat XT System generates a consistent vacuum pressure at the tip of the catheter to draw thrombus into the extraction ports where it is then macerated by an internal helix. Without further contact with the bloodstream, the thrombus is then transported to an external collection bag.
The ThromCat XT is disposable and offered in 150 cm length to treat vessels 2.5 mm to 7 mm in diameter.
The first use of the ThromCat XT System occurred in a procedure performed by Danny Nguyen, MD, in consultation with Michael Haude, MD, of the department of cardiology at Städtische Kliniken Neuss-Lukaskrankenhaus (Neuss, Germany). The intervention was performed on a 70-year-old female patient with heart failure and a totally occluded right coronary artery. Thrombectomy was successfully completed with the ThromCat XT, and was followed by direct stenting of the proximal and middle sections of the artery, restoring normal flow.
Haude and Nguyen said following the procedure, "We are very satisfied with the overall performance of the ThromCat XT. In contrast to the previous version of the ThromCat, the set-up time was significantly shortened, and the device was easy to use. In addition, this new version of the ThromCat provides better pushability and trackability within the vessel. The device was able to remove virtually all thrombus from a 100% occluded vessel that contained significant thrombus burden."
Study backs Cardiola's MCP
Cardiola AG (Winterthur, Switzerland) said that data from a study, "Safety and efficacy of ECG-triggered muscular counterpulsation for hemodynamic improvement of cardiac function," presented at the annual congress of the Swiss Society of Cardiology demonstrates that MCP [muscular counterpulsation] is safe and efficient for improving cardiac function in patients with coronary artery disease (CAD).
One of the study's investigators was Professor Beat Walpoth, director of cardiovascular research, clinical and experimental, at University Hospital (Geneva, Switzerland).
In the study, peripheral resistance of CAD patients was decreased by 22%; end diastolic pressure was reduced by 18%; and stroke work was reduced by 16%. Additionally, there was a 12% increase in cardiac index.
"Given the promising results of this and many previous clinical studies, it is well-established that MCP – the proprietary technology platform of our patented m.pulse device – is a safe and effective therapy designed to improve the hemodynamic function of a failing heart," said Christof Lenz, Cardiola CEO. "With regulatory approval now in place in Europe, the m.pulse system is offering patients a well-validated, affordable and non-surgical treatment alternative that they themselves can perform in their own home."
Cardiola's m.pulse device, based on the company's MCP technology, is approved in Europe for treating CHF as a nonsurgical, at-home therapy.
Battery-powered m.pulse, the size of a cell phone that the patient attaches to his belt for about 45 minutes per treatment, is synchronized to his cardiac cycle to stimulate the muscles of the calves and thighs to make them contract in the resting phase of the heart. This well-established counterpulsation action results in increased blood flow to the heart muscle while decreasing the heart's workload.
Counterpulsation previously only was available in a clinical setting. m.pulse is the first device enabling CHF patients to receive MCP therapy at home.