Pounce Thrombus Retrieval System Receives FDA Approval – Non-Surgical Removal of Thrombi and Emboli from the Peripheral Arterial Vasculature

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

September 23, 2020

Pounce Thrombus Retrieval System has received FDA approval.  The news was announced today by Surmodics.

The Pounce Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. Depending on the age and magnitude of the occlusion and the viability of the threatened limb, existing treatments for this condition may include catheter-directed thrombolysis, surgical embolectomy, and/or percutaneous mechanical thrombectomy. In cases in which the occlusion has caused irreversible damage to the limb, acute limb ischemia can result in the amputation of a lower extremity.

The Pounce Thrombus Retrieval System is a mechanical thrombectomy device that facilitates thrombus removal in peripheral vasculature without the added expense or commitment to any additional, external capital equipment.

“The FDA 510(k) clearance of our Pounce Thrombus Retrieval System brings us one step closer to providing a technology that offers significant advances over the current treatment of complex, peripheral artery disease (PAD),” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “This approval also demonstrates Surmodics’ deep R&D capabilities and we are excited to ramp up our development efforts on new clinical applications for deep vein thrombosis (DVT), pulmonary embolism (PE) and ischemic stroke.”

The device is comprised of three components: a 5 Fr basket delivery catheter, a basket wire assembly, and a trumpet assembly. After the basket wire assembly is delivered distal to the location of the thrombus, two nitinol self-expanding baskets are deployed to collect and entrain the clot into a trumpet-shaped nitinol wire mesh. With the clot entrained, the trumpet assembly is then collapsed into a 7 Fr guide sheath through which the clot is withdrawn and removed from the body.

“The Surmodics team has done an excellent job finalizing the product design and advancing the Pounce Thrombus Retrieval System into a medical device that has the potential to change the treatment algorithm for arterial thrombectomy, ” said Gary Ansel, MD, Founder and former Chief Medical Officer of Embolitech, from which  Surmodics. acquired the technology and intellectual property behind the Pounce Thrombus Retrieval System. “By providing peripheral interventionalists with an innovative, non-surgical tool for treating arterial thrombotic occlusions, the Pounce Thrombus Retrieval System will serve an important clinical need and is a great fit with the Company’s focus on advancing therapies for peripheral artery disease.”

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.