Malin Corporation Wins Marketing Clearance for Peripheral Embolization Plug
Malin Corporation secured 510(k) clearance for its Hourglass Peripheral Embolization Plug.
The device enables accurate, stent-like delivery, allowing physicians to securely deliver the plug for immediate occlusion of the blood vessel. It is already approved in Europe.
FDA Approves Abbott’s HeartMate 3 Implantable Pump
Abbott received 510(k) clearance for the HeartMate 3 implantable pump for heart failure patients awaiting a transplant.
The approval is the latest for the HeartMate line of left ventricular assist devices first developed by Thoratec. Thoratec was brought to Abbott in a $25 million merger earlier this year after they were acquired by St. Jude Medical.
The device features magnetic levitation in the pump’s impeller, resulting in less trauma to blood cells as they pass through. The device won CE Mark approval in the European Union in October 2015.
Regentis Biomaterials Gets Expanded CE Mark for GelrinC
Regentis Biomaterials received an expanded CE Mark in the European Union for its GelrinC hydrogel-based resorbable treatment for focal cartilage defects in the knee, covering GelrinC products manufactured using denatured human fibrinogen.
The approval expands on previous approvals clearing versions of the device manufactured using denatured bovine-sourced fibrinogen. The GelrinC implant is designed to naturally degrade within 6 to 12 months as it’s replaced by cartilage.
FDA Approves Tandem’s Insulin Pump
Tandem Diabetes Care received FDA approval of its t:slim X2 Insulin Pump with Dexcom G5 Mobile continuous glucose monitoring integration.
The device is the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger.
The pump’s software will also be available to current t:slim X2 Pump users at no cost.
C.R. Bard Lands Additional Indication for Drug-Coated Balloon Catheter
C.R. Bard received premarket approval from the FDA for its drug-coated balloon CTA catheter for a new indication for end-stage renal disease.
The device is the first and only drug-coated balloon approved for ESRD patients with stenotic lesions. The device was previously approved for treatment of superficial femoral artery and popliteal artery disease.
Medtronic Gets CE Mark for Left Heart Lead
Medtronic has received a CE Mark for its Attain Stability Quad MRI SureScan Left Heart lead in Europe. The device works with the company’s quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and CRT-pacemakers (CRT-P).
The unit features a helix that works like an anchor to secure the lead, adapting to the anatomy of each individual patient. The device is currently undergoing a clinical trial in the U.S.