K-Pack Surshield Hypodermic Needle

Terumo Medical Corporation (Somerset, NJ) recently received 510(k) clearance from the US Food and Drug Administration to market the new K-Pack Surshield hypodermic needle featuring integrated, passive sharps protection for use with prefilled syringes for intramuscular and subcutaneous pharmaceutical applications. The K-Pack Surshield comes individually packaged and sterile in a rigid container with a tamper-evident and colorcoded label. US Customers will have access to the K-Pack Surshield with Terumo's high-quality 25-g X 0.625-inch or 27-g X 0.5-inch needles designed for minimal patient trauma.

“Terumo's innovative K-Pack Surshield offers exceptional performance and safety for the health care professional,” said Juichi (Jim) Takeuchi, President and CEO, of Terumo Medical Corporation.


Sensation Plus Intra- Aortic Balloon Catheter

Maquet Cardiovascular (Mahwah, NJ) has received both US Food and Drug Administration 510(k) clearance and CE Mark approval for its Sensation Plus 50-mL 8-F intra-aortic balloon (IAB) catheter. Sensation Plus is the first 50-mL 8-F IAB catheter to combine fiber-optic signal acquisition with greater hemodynamic support compared to a standard 40-mL IAB catheter, the company stated.

The 50-mL 8-F Sensation Plus IAB catheter provides greater patient support, comfort, and ease of use than any previous IAB catheter from Maquet. Sensation Plus incorporates fiber-optic signal acquisition and provides 25% more blood volume displacement than standard 40-mL IAB catheters, allowing for improved unloading and better augmentation. This new IAB catheter also comes with two StatLock IAB stabilization devices that allow the catheter to be secured to the patient's leg without sutures, which is more comfortable for patients and eliminates the risk of suture needle sticks for clinicians when initiating counterpulsation support.