According to a press release, Biophan Technologies Inc. has finalized an $11 million cash deal with Medtronic Inc., in which the Pittsford, NY-based company is selling to Medtronic all rights to its patents to make implantable gadgets, like pacemakers and defibrillators, MRI safe. (The complete list of Biophan’s patents can be found here.) The deal will allow Biophan to invest its extra cash into Myotech LLC (West Henrietta, NY), a developer of the MYO-VAD™ circulatory assist device, a system that was first reported here in July, 2006. For now, it seems, the system has been re-branded as The Myotech Circulatory Support System (CSS). Biphan has exclusive rights to market and distribute the device, if, and when, it is approved by the FDA.
The company is quite optimistic about the system:
The Myotech CSS is the first in a family of products based upon Direct Mechanical Ventricular Actuation (DMVA) technology. It consists of a flexible polymer “cup” that can be installed around the heart in approximately three minutes. Incorporating a pneumatically activated liner, the Myotech CSS operates by compressing and expanding bi-directionally, providing the energy that allows the heart to restore the blood flow to normal, life sustaining levels. A previous version of the technology has been installed in over 700 animals and helped to save human lives in emergency–use situations. Following substantial improvements to the technology, the Myotech CSS is now ready for commercialization.
The Myotech CSS energizes the best blood pump known to man: the human heart. Since it does not contact circulating blood, like virtually all existing cardiac assist devices, the Myotech CSS has the potential to reduce or avoid complications which plague existing devices, including clotting and stroke, bleeding, and infection. Additionally, the healing environment created by the Myotech CSS has the potential to rehabilitate many sick hearts, allowing the device to be removed and the heart to function properly again without assistance…
Recent medical studies (REMATCH) have shown that the therapeutic benefit of a cardiac assist device is superior to medical management alone (i.e. drug therapy) for the treatment of heart failure. However, the cost of existing devices and levels of patient complications remain unacceptable. The Myotech CSS promises to be safer, more effective, less expensive (total procedure cost), broadly available (not just specialized transplant or cardiac centers), and reimbursable under existing guidelines.
The first embodiment of the Myotech CSS to be introduced will enable the physician to quickly restore cardiac function and blood flow to stabilize heart failure patients and provide the precious time needed to deliver the proper therapy. Compared to conventional ventricular assist devices (VAD) that take 45 minutes to two hours to install with major surgery, the Myotech CSS can be installed in approximately three minutes. This procedure could potentially be performed in life-saving emergency situations in virtually every hospital.
The Myotech CSS does not contact circulating blood, which dramatically reduces the risk of complications common to existing cardiac assist devices. While existing cardiac assist devices usually address only one aspect of heart failure, typically by assisting the emptying of the left ventricle only, the Myotech CSS is designed to actively support both filling and emptying of the right and left ventricles. This is a critically important capability since many forms of heart failure affect more than emptying of the left ventricle. According to the NEJM, 20-50% of congestive heart failure (CHF) patients are in pure diastolic (filling) failure, with 1/3 a good consensus. Additionally, many patients are in combined failure, with components of both systolic (emptying) and diastolic dysfunction degrading the performance of their heart. No other device assists the diastolic phase of pumping. We believe this broad range of capability will extend the potential uses of this device in treating many forms of both acute and chronic heart failure, including congestive heart failure. The possibility of treating a wide range of heart failure disease types with fewer complications increases the potential market for this product.
Once approved by the FDA, it is anticipated that the Myotech CSS will be 100% reimbursable under pre-existing reimbursement codes.