Puzzle Medical Devices was announced as the winner of the Shark Tank innovation competition at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA).
The company is developing a novel circulatory support device that is implanted percutaneously in the abdominal aorta—known as ModulHeart. The device provides haemodynamic support through three endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta.
Puzzle Medical designed the ModulHeart device for patients with advanced heart failure (HF) who are not candidates for heart transplant or surgical mechanical circulatory support. The design of the device is intended to enable safe percutaneous implantation, with low risk of bleeding, stroke, and pump thrombosis, while providing sustained symptom relief, reduced rehospitalisation and improved overall quality of life.
Results from the device’s first-in-human study showed 100% procedural success in four patients who received circulatory support whilst undergoing high-risk percutaneous coronary intervention (PCI). In addition, cardiac output among these patients increased by 25%, urine output increased by nine-fold, and left ventricular end-diastolic pressure decreased by 78%, Puzzle Medical has reported.
“I am extremely pleased with the ﬁrst series of cases performed. Device implantation and explantation were easy and technically successful. The pumps functioned as expected and provided patients with signiﬁcant improvement in hemodynamic parameters. I am excited about Puzzle Medical’s progress and the potential for this device to disrupt HF treatment,” said Philippe Genereux (Morristown Medical Center, Morristown, USA) of the first-in-human procedures.
ModulHeart has received US Food and Drug Administration (FDA) breakthrough device designation, and an initial indication is being pursued for in-hospital therapy of acute decompensated heart failure (ADHF).
Puzzle Medical saw off competition from a number of early stage companies to scoop the US$200,000 Shark Tank prize, including Magneto, developer of a pulmonary embolism solution, Solopace, with a purpose built pacing system for transcatheter aortic valve implantation (TAVI), Cardionomic and its cardiac autonomic modulation therapy, Restore Medical, developing pulmonary banding for HF treatment, and NXT Biomedical, which entered with a pulmonary to venous shunt for pulmonary hypertension in patients with heart failure and preserved ejection fraction (PH-HFpEF).
“We are excited to name Puzzle Medical as this year’s TCT Shark Tank Innovation Competition winner,” said Juan F Granada, president and chief executive officer of the Cardiovascular Research Foundation (CRF), the sponsor of TCT. “Their ModulHeart device has the potential to change the course of treatment for heart failure patients in a minimally invasive way.”
Granada presented Genereux and the Puzzle Medical team with the award at TCT 2022, alongside Robert Schwartz, president of the Jon DeHaan Foundation, which has supported the last five editions of the competition.
“It is an honour to be recognised by CRF and the Jon DeHaan Foundation,” said Jade Doucet-Martineau, co-founder and CEO of Puzzle Medical Devices. “Our team is grateful to have been chosen from the other innovative companies that presented at this year’s TCT Shark Tank innovation competition. With the successful completion of our first-in-human study, further investigations are underway using the ModulHeart device.”
“CRF is truly grateful to the Jon DeHaan Foundation for their continued support of pioneers in the field dedicated to developing novel technologies for the diagnosis and treatment of cardiovascular diseases,” added Granada.