Optimizer® Smart System

Impulse Dynamics has developed the Optimizer® Smart system with CCM™ (Cardiac Contractility Modulation) technology to ease the symptoms of CHF for these patients. CCM therapy delivers precisely timed electrical pulses to the heart cells during a special period of the beating cycle (called the absolute refractory period, or the period just after the heart contracts). In doing so, it strengthens and helps the heart contract more forcibly, thereby delivering more blood and oxygen to the body. Studies have shown CCM therapy to improve 6-minute hall walk distance, quality of life and functional status among patients who are candidates for the device.1

The Optimizer® Smart System includes an implantable stimulation device (similar in size to a pacemaker) and external charging station. The device is implanted in a small pocket under the skin of the upper chest, along with commercially available pacemaker leads that are placed in the heart’s right ventricular septum, while the patient is under light sedation. After implantation, the physician custom-programs and activates the device for the patient. The Optimizer® Smart then begins sending electrical pulses to the heart muscle for a total of 5 to 7 hours a day, in one-hour treatments separated by regular intervals. The patient charges the device one hour per week, using the external charger. The Optimizer® Smart device is expected to last at least 15 years without replacement. The implant procedure doesn’t require open-heart surgery and most patients can return home soon after the implant is complete. Plus, most patients are able to return to everyday activities shortly after the procedure.

Principle Investigator:

Dr. Charles Jost, MD

“For Physicians: The Optimizer® Smart by Impulse Dynamics.” Impulse Dynamics, 25 Aug. 2020, impulse-dynamics.com/providers/
“For Patients: The Optimizer® Smart by Impulse Dynamics.” Impulse Dynamics, 1 Sept. 2020, impulse-dynamics.com/patients/

PQ Bypass

Torus2 – Stent Graft System

The TORUS 2 IDE Clinical Study is a prospective, single-arm, multi-center clinical investigation to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the superficial femoral and/or proximal popliteal arteries. The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.3

Principle Investigator:
Dr. Nachiket Patel, MD

“TORUS 2 IDE Clinical Study – Full Text View.” Full Text View – ClinicalTrials.gov, clinicaltrials.gov/ct2/show/NCT04130737.

These are the currently published papers w/respective links:

Charles MT Jost, Nachiket J. Patel, Sam Dierks, et al. Use of the Versatile Medtronic SilverHawk DS Plaque Excision System to Recanalize the Pedal Arterial Loop for Maximal Luminal Restoration. CLD. 2020;28(3). https://www.cathlabdigest.com/content/SilverHawkCLD

As we continue to treat lower extremity PAD, chronic total occlusions, and CLI patients more distally, we must continue to explore the capabilities of available devices. In this case, we chose to test the efficacy of the SilverHawk DS atherectomy device beyond its typical distal reach and function, and advance further across the pedal loop and distal arterial vessels of the feet. The SilverHawk, TurboHawk, and HawkOne directional atherectomy devices (Medtronic) have proven to be versatile and effective in treating challenging atherosclerosis with resistive calcified plaque in most of the arteries of the lower extremities.7 The SilverHawk DS device proved to be just as effective in removing plaque in the pedal loop compared to its use in the more proximal vessels, given a cooperative vascular setting. This case demonstrates a successful clinical outcome using existing directional atherectomy technology across the distal plantar and pedal loop arteries.

Macdonald K, Minkus K, Jost C. Use of Excimer Laser to Facilitate CTO Crossing Complicated by Stent Fracture. CLD. 2020;28(10). https://www.cathlabdigest.com/article/Use-Excimer-Laser-Facilitate-CTO-Crossing-Complicated-Stent-Fracture

The first case report of coronary stent fracture was described in 2004.5 The conventional treatment for stent fracture and ISR varies between solitary medical treatment, balloon angioplasty, and re-stenting using DES.6 High-energy excimer laser has been used to treat coronary ISR in an underexpanded stent not amenable to high-pressure balloon angioplasty.2 Latib and Colombo describe the use of ELCA to modify the plaque by using contrast injection to further improve stent underexpansion in undilatable stented lesions.7 This laser “explosion” technique was previously described by Nicola Viceconte.8 While rotational atherectomy is a relative contraindication for ISR and underexpanded stents, this modality of treatment has been used at times with success.7 In our case, the stent fracture led to symptomatic and severe ISR, and as an uncrossable/undilatable obstruction, was a contraindication for rotational or orbital atherectomy. The prolonged use of focal and proximal ELCA treatment, leading to the maximum fluence of 80 mJ/mm2, was instrumental in plaque modification that permitted the passing of a larger balloon at high pressure and finally, a drug eluding stent (DES). This collective procedural approach significantly reduced the ISR, satisfactorily treated and resolved the coronary stent obstruction, and restored adequate blood flow through the coronary vessels, with the expectation of excellent long-term patency.