Approvals

FDA Clears Subcutaneous Remodulin Delivery System

The FDA granted United Therapeutics and DEKA 510(k) clearance for the RemUnity subcutaneous delivery system for Remodulin (treprostinil), a continuous pump therapy used to treat pulmonary arterial hypertension.

The lightweight pump controls the drug’s flow rates without the use of a motor using acoustic volume sensing technology and a solid-state actuator. The pump has a service life of at least three years.

United Therapeutics and DEKA are also developing a version of the device that uses prefilled disposable cartridges.

Boston Scientific Gains FDA Nod for Venous Stent

Boston Scientific has earned the FDA’s premarket approval for the Vici Venous Stent system, a device used for treating iliofemoral venous obstructive disease.

Venous obstructive disease occurs when blood flow in the pelvic veins is compressed or blocked by a blood clot.

The stent’s approval was based on data from a multi-center trial with 170 patients. The VIRTUS study met its primary safety and effectiveness endpoints.

The stent resists the compression encountered frequently in the iliofemoral venous system through its strong and crush resistant design and restores blood flow by creating a cylindrical vessel.

Medtronic’s iPad-Based Pacemaker Programmer Receives FDA Clearance

The FDA has cleared Medtronic’s CareLink SmartSync system, a pacemaker manager platform that programs and downloads data from cardiac implants using the Apple iPad.

The Bluetooth-capable system comes with a patient connector, telemetry head, base station and pacing system that weighs a little over two pounds when used with the iPad tablet.

The next-generation programmer and pacing system features encrypted data monitoring and is designed to replicate the interface of Medtronic’s similar device, the CareLink 2090.

SentreHeart’s Left Atrial Appendage Closure Device Gets CE Mark

SentreHeart earned the CE Mark for the 50mm version of its LARIAT-RS left atrial appendage (LAA) closure device.

Using imaging guidance, the LARIAT delivers a suture loop at the base of the LAA. Over time, the appendage disappear, so it is no longer a source of blood clots in patients with atrial fibrillation.

SentreHEART is conducting the aMAZE trial in up to 65 centers in the United States that seeks to show that the LARIAT procedure followed by a catheter ablation can reduce the incidence of recurrent atrial fibrillation.

The new 50mm device is now available in Europe along with the 45mm version.

Biofourmis’ ECG Monitor Cleared by FDA for Sensing Cardiac Arrhythmias

The FDA granted 510(k) clearance for Biofourmis’ RhythmAnalytics, an ECG monitoring device for detecting heart arrhythmias.

The monitor automatically analyzes heart arrhythmias and can detect 15 different types, including ventricular arrhythmias, ventricular ectopic beats and atrial fibrillation.

The device uses artificial intelligence models formed using over a million ECG recordings from multiple wearable monitors approved by the FDA.

FDA Approves Medtronic’s Left Heart Lead

The FDA has given the green light for Medtronic’s Attain Stability Quad MRI SureScan, a left heart lead device designed to be used with the company’s defibrillators and pacemakers.

The device allows physicians to place the lead accurately in veins of various sizes, including ones in which positioning is difficult.

The lead enables physicians to “target the ideal location in the patient’s vessel with the confidence that the lead will remain in place to allow for continued effective delivery of cardiac resynchronization therapy,” said Steven Zweibel, director of electrophysiology at the Hartford Healthcare Heart and Vascular Institute.